Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total…
- Trial name
- PTAB1 (NCT06315023)
- Testing
- DETOUR System
- Where
- 10 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix
Peripheral Arterial Occlusive Disease
Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before…
- Trial name
- BLOC-FEMPOP (NCT01785693)
- Testing
- levobupivacaine, clonidine
- Where
- France
- Volunteers
- 47 people
- Sponsor
- University Hospital, Clermont-Ferrand
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
- Trial name
- TRANSCEND (NCT03241459)
- Testing
- Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 446 people
- Sponsor
- SurModics, Inc.
Peripheral Artery Disease, Claudication
Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries
The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months…
- Conditions
- Peripheral Artery Disease, Claudication, Atherosclerosis, Arteriosclerosis
- Trial name
- RANGER-SFA (NCT02013193)
- Testing
- Ranger DCB, uncoated PTA balloon
- Where
- 11 sites in Austria, France and 1 more
- Volunteers
- 105 people
- Sponsor
- Hemoteq AG
Peripheral Arterial Disease
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
- Trial name
- PQB4FP1 (NCT01930071)
- Testing
- PQ Bypass Guide Wire Delivery System
- Where
- New Zealand
- Volunteers
- 4 people
- Sponsor
- Endologix
Femoropopliteal In-Stent Restenosis (ISR)
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment.
- Trial name
- NCT07277218
- Testing
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Where
- 10 sites in China
- Volunteers
- 600 people
- Sponsor
- Chunshui He
Peripheral Arterial Disease, Calcifications Vascular
SOLUTION Trial in China
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
- Trial name
- NCT05434676
- Testing
- Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
- Where
- 5 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Peripheral Arterial Disease
A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.
This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded)…
- Trial name
- FP-Restore (NCT04801004)
- Where
- China
- Volunteers
- 322 people
- Sponsor
- Shanghai Zhongshan Hospital
Peripheral Artery Disease
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
- Trial name
- NCT01628159
- Testing
- Lutonix Drug Coated Balloon
- Where
- 64 sites in United States, Austria and 3 more
- Volunteers
- 657 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Claudication
Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient
1. To perform an observational analysis to determine if mean translesional gradient measurements (TLG) are associated with differences in clinical outcomes in patients with femoropopliteal arterial disease and claudication. 2.
- Trial name
- NCT02387658
- Testing
- translesional gradient measurement
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- North Texas Veterans Healthcare System
Peripheral Vascular Disease
The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery for the Treatment The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery of Femoropopliteal TASC C&D Lesions
The objective of this clinical investigation is to evaluate the early and mid-term outcome (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX paclitaxel-eluting stent (Cook) versus bypass…
- Trial name
- ZILVERPASS (NCT01952457)
- Testing
- Zilver PTX, prosthetic bypass
- Where
- 5 sites in Belgium
- Volunteers
- 220 people
- Sponsor
- Flanders Medical Research Program
Peripheral Arterial Disease, Peripheral Artery Disease
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
- Trial name
- PREVISION (NCT05556681)
- Testing
- BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
- Where
- 10 sites in Australia, New Zealand and 1 more
- Volunteers
- 34 people
- Sponsor
- C. R. Bard
Peripheral Vascular Disease
DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg.
- Trial name
- REALITY (NCT02850107)
- Testing
- Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB, Medtronic Spider™ Distal Protection Device (DPD)
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- VIVA Physicians
Peripheral Arterial Disease
A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon…
- Trial name
- BIOPACT-RCT (NCT03884257)
- Testing
- Passeo-18 Lux treatment group, IN.PACT Admiral treatment group
- Where
- 14 sites in Austria, Belgium and 2 more
- Volunteers
- 302 people
- Sponsor
- KANDO Research
Peripheral Arterial Disease
Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon
Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population.
- Trial name
- NCT05616520
- Testing
- drug-coated balloon
- Where
- China
- Volunteers
- 838 people
- Sponsor
- Xuanwu Hospital, Beijing
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Vascular Diseases, Stent Complication
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years.
- Trial name
- NCT05522218
- Testing
- Eluvia drug eluting stent
- Where
- China
- Volunteers
- 400 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease, Vascular Diseases
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Stenosis, Femoropopliteal Stenosis
- Trial name
- Efemoral I (NCT04584632)
- Testing
- Efemoral Vascular Scaffold System (EVSS)
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- Efemoral Medical, Inc.
Femoropopliteal Disease, Intermittent Claudication
Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-popliteal Disease
Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of the legs on exertion caused by "hardening of the arteries" and a reduced blood supply.
- Trial name
- NCT00798850
- Testing
- Percutaneous Transluminal Angioplasty (PTA), Supervised Exercise Programme (SEP), Combined Treatment
- Where
- United Kingdom
- Volunteers
- 178 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust