Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee
Journal of Endovascular Therapy
Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal ... more Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal arteries including investigational drug-coated balloons have limited long-term efficacy. Objectives: This Phase 2 trial assessed the feasibility of adventitial deposition of temsirolimus to reduce neointimal hyperplasia and clinically relevant target lesion failure (CR-TLF) 6 months after BTK arterial revascularization. Methods: This prospective, multicenter, double-blinded, comparative, dose-escalation trial enrolled 61 patients with Rutherford 3 to 5 symptoms undergoing endovascular revascularization of ≥1 angiographically significant BTK lesions. Perivascular infusion after completion of arterial revascularization was randomized into control (saline) vs low-dose (0.1 mg/mL) temsirolimus groups for the first 30 patients. In the second part of the trial, patients were randomized to control versus high-dose (0.4 mg/mL) temsirolimus groups. Primary and secondary efficacy endpoints were ta...
Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of i... more Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evalua...
Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exempt... more Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study ( ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety e...
PURPOSE To assess the performance and safety of a dedicated venous stent (Venovo Venous Stent, Be... more PURPOSE To assess the performance and safety of a dedicated venous stent (Venovo Venous Stent, Becton Dickinson) for the treatment of iliofemoral vein occlusive disease. METHODS AND MATERIALS 170 patients were enrolled in the intentto-treat population, 93 post-thrombotic syndrome patients (PTS) and 77 non-thrombotic iliac vein lesion patients (NIVL); the VERNACULAR study was conducted at 22 centers in the United States, Europe, and Australia. Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), and target lesion revascularization (TLR) at 24 months. Radiographs were assessed for stent fracture by an independent core laboratory.
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disea... more Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or sten...
Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not bee... more Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria,
Approximately 27 million people in Europe and North America currently have peripheral arterial di... more Approximately 27 million people in Europe and North America currently have peripheral arterial disease (PAD). The endovascular treatment of stenosis or blocked peripheral arteries in PAD include percutaneous transluminal angioplasty with or without a drug coated balloon (DCB), atherectomy (rotational, directional, orbital or laser), and stenting. The development of next generation peripheral stents and drug-coated stents have led to the improved treatment of complex superficial femoral artery (SFA) lesions, and consequently increased their usage. Additionally, the technologies developed for PAD intervention have further improved the overall adoption of endovascular procedures leading to increased utilization of stents to address procedural dissections (bailout stenting), as support scaffolding for complex lesions, and to prevent preventing elastic recoil post balloon angioplasty. For example, bail-out stenting after DCB angioplasty has been reported to be as high as 40% in long lesi...
The pedal revolution – From exotic to routine: A step by step approach to pedal artery retrograde access and intervention – Adapted from an oral presentation from APVIC VII
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology, 2015
The critical threshold and clinical significance of transient ischemic dilation (TID) for regaden... more The critical threshold and clinical significance of transient ischemic dilation (TID) for regadenoson, single-isotope (99m)Tc SPECT myocardial perfusion imaging (MPI) are not defined. From 100 patients with low likelihood of CAD, we derived the abnormal TID threshold (mean + 2 SD). We validated the threshold in a cohort of 547 patients who received one-day, rest/regadenoson-stress, (99m)Tc-tetrofosmin SPECT-MPI followed by coronary angiography within 6 months. Patients were classified into three CAD severity strata: no significant CAD, mild to moderate CAD, and severe and extensive CAD. The abnormal TID threshold was determined to be 1.31. Though mean TID ratios were different between the three CAD severity groups and the derivation cohort (P < .001), there was no difference in the mean TID ratios between the categories of CAD severity or in the prevalence of severe CAD between TID+ and TID- groups (P = .74). By ROC analysis, TID had a poor discriminatory capacity in identifying ...
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, Jun 1, 2017
To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherect... more To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissu...
Six-month pivotal results of tack optimized balloon angioplasty using the Tack Endovascular System in below-the-knee arteries
Journal of Vascular Surgery, 2020
OBJECTIVE There is no vascular implant commercially available in the U.S. to treat post-angioplas... more OBJECTIVE There is no vascular implant commercially available in the U.S. to treat post-angioplasty dissections in below-the-knee (BTK) arteries. The Tack Endovascular System® is purpose-built to repair post-percutaneous transluminal angioplasty (PTA) BTK dissections. A trial was conducted to investigate the safety and efficacy of the first-of-a-kind implantable BTK device to treat post-PTA dissections in the setting of critical limb ischemia. METHODS This prospective, single arm, multi-center study evaluated the Tack Endovascular System for treating post-PTA dissections in the mid/distal popliteal, tibial, and peroneal arteries. The primary safety endpoint is major adverse limb events (MALE) + perioperative death (POD), assessed at 30 days post index procedure; the primary efficacy endpoint is a composite of major adverse limb events (MALE) at 6 months and POD; and the unpowered secondary endpoint is primary patency at 6 months. With no available on-label comparator, the primary endpoints of this trial were determined using objective performance goals (OPGs) from a systematic literature search. Secondary endpoints included Tacked segment(s) patency and target limb salvage (TLS) at 6 months. Six-month results are reported. RESULTS Of the 233 patients enrolled, 50.2% (117/233) were Rutherford 5, and 33.5% (78/233) were Rutherford 4. 341 post-PTA dissections were treated. Each patient received at least one Tack implant, and 100% of dissections were resolved per angiographic core laboratory. Both primary safety and efficacy endpoints were met: MALE + POD at 30 days was 1.3% (3/228), and freedom from MALE at 6 months + POD at 30 days was 95.6% (196/205). Six-month Tacked segment patency was 82.1% (247/301) and TLS was 98.5% (202/205). Kaplan-Meier freedom from CD-TLR and amputation-free survival at 6 months were 92.0% and 95.7%, respectively. Rutherford improvement was reported in 79.4% (158/199). Most (90/122, 73.8%) pre-existing wounds were healed or improving. CONCLUSIONS The Tack Endovascular System is safe and effective for treating post-PTA BTK dissections through six months, with favorable rates of MALE + POD, patency, CD-TLR, limb salvage, and wound healing.
The treatment and management of patients with in-stent restenosis (ISR) remains an important clin... more The treatment and management of patients with in-stent restenosis (ISR) remains an important clinical challenge. ISR cases involving the superficial femoral and popliteal arteries are complex due to the potential for multivariable complications, including severe neointimal proliferation, stent fracture, and increased restenosis lesion length. We present a challenging superficial femoral artery ISR chronic total occlusion in a 66-year-old female with a history of severe vascular disease. She presented with rest pain and computed tomography angiographic evidence of moderate calcification surrounding a re-occluded drug-eluting stent. The ISR disease morphology and distribution were visualized and removed using optical coherence tomography (OCT)-guided directional atherectomy. Avinger's Pantheris catheter is the first therapeutic device to incorporate real-time OCT for intravascular imaging. OCT provides visualization without the need for contrast or x-ray radiation. This case demonstrates the successful recanalization of a complex superficial femoral artery ISR chronic total occlusion utilizing the Pantheris catheter.
Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee
Journal of Endovascular Therapy
Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal ... more Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal arteries including investigational drug-coated balloons have limited long-term efficacy. Objectives: This Phase 2 trial assessed the feasibility of adventitial deposition of temsirolimus to reduce neointimal hyperplasia and clinically relevant target lesion failure (CR-TLF) 6 months after BTK arterial revascularization. Methods: This prospective, multicenter, double-blinded, comparative, dose-escalation trial enrolled 61 patients with Rutherford 3 to 5 symptoms undergoing endovascular revascularization of ≥1 angiographically significant BTK lesions. Perivascular infusion after completion of arterial revascularization was randomized into control (saline) vs low-dose (0.1 mg/mL) temsirolimus groups for the first 30 patients. In the second part of the trial, patients were randomized to control versus high-dose (0.4 mg/mL) temsirolimus groups. Primary and secondary efficacy endpoints were ta...
Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of i... more Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evalua...
Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exempt... more Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study ( ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety e...
PURPOSE To assess the performance and safety of a dedicated venous stent (Venovo Venous Stent, Be... more PURPOSE To assess the performance and safety of a dedicated venous stent (Venovo Venous Stent, Becton Dickinson) for the treatment of iliofemoral vein occlusive disease. METHODS AND MATERIALS 170 patients were enrolled in the intentto-treat population, 93 post-thrombotic syndrome patients (PTS) and 77 non-thrombotic iliac vein lesion patients (NIVL); the VERNACULAR study was conducted at 22 centers in the United States, Europe, and Australia. Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), and target lesion revascularization (TLR) at 24 months. Radiographs were assessed for stent fracture by an independent core laboratory.
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disea... more Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or sten...
Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not bee... more Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria,
Approximately 27 million people in Europe and North America currently have peripheral arterial di... more Approximately 27 million people in Europe and North America currently have peripheral arterial disease (PAD). The endovascular treatment of stenosis or blocked peripheral arteries in PAD include percutaneous transluminal angioplasty with or without a drug coated balloon (DCB), atherectomy (rotational, directional, orbital or laser), and stenting. The development of next generation peripheral stents and drug-coated stents have led to the improved treatment of complex superficial femoral artery (SFA) lesions, and consequently increased their usage. Additionally, the technologies developed for PAD intervention have further improved the overall adoption of endovascular procedures leading to increased utilization of stents to address procedural dissections (bailout stenting), as support scaffolding for complex lesions, and to prevent preventing elastic recoil post balloon angioplasty. For example, bail-out stenting after DCB angioplasty has been reported to be as high as 40% in long lesi...
The pedal revolution – From exotic to routine: A step by step approach to pedal artery retrograde access and intervention – Adapted from an oral presentation from APVIC VII
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology, 2015
The critical threshold and clinical significance of transient ischemic dilation (TID) for regaden... more The critical threshold and clinical significance of transient ischemic dilation (TID) for regadenoson, single-isotope (99m)Tc SPECT myocardial perfusion imaging (MPI) are not defined. From 100 patients with low likelihood of CAD, we derived the abnormal TID threshold (mean + 2 SD). We validated the threshold in a cohort of 547 patients who received one-day, rest/regadenoson-stress, (99m)Tc-tetrofosmin SPECT-MPI followed by coronary angiography within 6 months. Patients were classified into three CAD severity strata: no significant CAD, mild to moderate CAD, and severe and extensive CAD. The abnormal TID threshold was determined to be 1.31. Though mean TID ratios were different between the three CAD severity groups and the derivation cohort (P < .001), there was no difference in the mean TID ratios between the categories of CAD severity or in the prevalence of severe CAD between TID+ and TID- groups (P = .74). By ROC analysis, TID had a poor discriminatory capacity in identifying ...
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, Jun 1, 2017
To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherect... more To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissu...
Six-month pivotal results of tack optimized balloon angioplasty using the Tack Endovascular System in below-the-knee arteries
Journal of Vascular Surgery, 2020
OBJECTIVE There is no vascular implant commercially available in the U.S. to treat post-angioplas... more OBJECTIVE There is no vascular implant commercially available in the U.S. to treat post-angioplasty dissections in below-the-knee (BTK) arteries. The Tack Endovascular System® is purpose-built to repair post-percutaneous transluminal angioplasty (PTA) BTK dissections. A trial was conducted to investigate the safety and efficacy of the first-of-a-kind implantable BTK device to treat post-PTA dissections in the setting of critical limb ischemia. METHODS This prospective, single arm, multi-center study evaluated the Tack Endovascular System for treating post-PTA dissections in the mid/distal popliteal, tibial, and peroneal arteries. The primary safety endpoint is major adverse limb events (MALE) + perioperative death (POD), assessed at 30 days post index procedure; the primary efficacy endpoint is a composite of major adverse limb events (MALE) at 6 months and POD; and the unpowered secondary endpoint is primary patency at 6 months. With no available on-label comparator, the primary endpoints of this trial were determined using objective performance goals (OPGs) from a systematic literature search. Secondary endpoints included Tacked segment(s) patency and target limb salvage (TLS) at 6 months. Six-month results are reported. RESULTS Of the 233 patients enrolled, 50.2% (117/233) were Rutherford 5, and 33.5% (78/233) were Rutherford 4. 341 post-PTA dissections were treated. Each patient received at least one Tack implant, and 100% of dissections were resolved per angiographic core laboratory. Both primary safety and efficacy endpoints were met: MALE + POD at 30 days was 1.3% (3/228), and freedom from MALE at 6 months + POD at 30 days was 95.6% (196/205). Six-month Tacked segment patency was 82.1% (247/301) and TLS was 98.5% (202/205). Kaplan-Meier freedom from CD-TLR and amputation-free survival at 6 months were 92.0% and 95.7%, respectively. Rutherford improvement was reported in 79.4% (158/199). Most (90/122, 73.8%) pre-existing wounds were healed or improving. CONCLUSIONS The Tack Endovascular System is safe and effective for treating post-PTA BTK dissections through six months, with favorable rates of MALE + POD, patency, CD-TLR, limb salvage, and wound healing.
The treatment and management of patients with in-stent restenosis (ISR) remains an important clin... more The treatment and management of patients with in-stent restenosis (ISR) remains an important clinical challenge. ISR cases involving the superficial femoral and popliteal arteries are complex due to the potential for multivariable complications, including severe neointimal proliferation, stent fracture, and increased restenosis lesion length. We present a challenging superficial femoral artery ISR chronic total occlusion in a 66-year-old female with a history of severe vascular disease. She presented with rest pain and computed tomography angiographic evidence of moderate calcification surrounding a re-occluded drug-eluting stent. The ISR disease morphology and distribution were visualized and removed using optical coherence tomography (OCT)-guided directional atherectomy. Avinger's Pantheris catheter is the first therapeutic device to incorporate real-time OCT for intravascular imaging. OCT provides visualization without the need for contrast or x-ray radiation. This case demonstrates the successful recanalization of a complex superficial femoral artery ISR chronic total occlusion utilizing the Pantheris catheter.
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Papers by Jaafer Golzar