Clinical trials: Femoropopliteal Artery Occlusion
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease, Restenosis
Local Paclitaxel Delivery to Prevent Restenosis in Peripheral Arterial Disease
The purpose of this study is to determine if the addition of a catheter-based local delivery of paclitaxel into the peripheral arterial vessels in patients with peripheral arterial disease (PAD) and subsequent restenosis of the…
- Trial name
- ResTAP (NCT03858764)
- Sponsor
- Jane Phillips Medical Center
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SELUTION4SFA Trial
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 34 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Peripheral Vascular Disease, Peripheral Arterial Disease
EVERO Drug-coated Balloon (DCB) Randomized Trial
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero…
- Trial name
- NCT07144150
- Testing
- Evero DCB, Paclitaxel DCB
- Where
- 15 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
Peripheral Artery Disease
3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were…
- Trial name
- FIDJI (NCT06173960)
- Testing
- atherectomy
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
Peripheral Arterial Disease
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
- Trial name
- PACCOCATH_F (NCT00472472)
- Testing
- paclitaxel coated balloon catheter (device with drug)
- Where
- 2 sites in Germany
- Volunteers
- 87 people
- Sponsor
- University Hospital, Saarland
Peripheral Arterial Disease
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or…
- Trial name
- NCT02469532
- Testing
- Balloon Angioplasty, Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Arterial Disease
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
- Trial name
- NCT05894863
- Testing
- Smart flex stent
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RenJi Hospital
Peripheral Arterial Disease, Atherosclerosis
Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal…
- Trial name
- SCENARIO-FP (NCT02544555)
- Testing
- Intentional intraluminal approach, Intentional subintimal approach
- Where
- 3 sites in South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Korea University Guro Hospital
Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
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
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated…
- Trial name
- NCT06124755
- Testing
- Viabahn endoprosthesis group, Drug-coated balloon group
- Where
- China
- Volunteers
- 60 people
- Sponsor
- RenJi Hospital
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease (PAD)
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Femoropopliteal Occlusive Disease, Below-the-knee Obstruction
- Trial name
- NCT03414515
- Testing
- Endovascular intervention
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed
Peripheral Artery Disease
Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with…
- Trial name
- SIRONA (NCT04475783)
- Testing
- Percutaneous Transluminal Angioplasty (PTA)
- Where
- 22 sites in Austria, Germany
- Volunteers
- 478 people
- Sponsor
- Jena University Hospital
Peripheral Artery Disease
Zilver® PTX® in China
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
- Trial name
- NCT02171962
- Testing
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Where
- 9 sites in China
- Volunteers
- 178 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease (PAD)
Zilver PTX Post-Market Study in Japan
Japanese post market clinical study of the Zilver PTX device.
- Trial name
- NCT02254837
- Testing
- Zilver PTX Drug-Eluting Stent
- Volunteers
- 909 people
- Sponsor
- Cook Group Incorporated
Vascular Diseases, Diabetes
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts.
- Trial name
- DCLI-I (NCT01171703)
- Testing
- femoral-popliteal bypass, stent
- Where
- 3 sites in China
- Volunteers
- 70 people
- Sponsor
- Peking Union Medical College Hospital
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD)…
- Trial name
- NCT02701543
- Testing
- Ranger Drug Eluting Balloon, In Pact Drug Eluting Balloon
- Where
- Germany
- Volunteers
- 414 people
- Sponsor
- University of Leipzig