Clinical trials: Popliteal Artery Disease
Peripheral Arterial Disease (PAD)
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug…
- Trial name
- INPACT SFA I (NCT01175850)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- Germany
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
PAD - Peripheral Arterial Disease
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty…
- Trial name
- REACTIVATE I (NCT05455021)
- Testing
- Vessel Restoration System (VRS)
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Alucent Biomedical
Peripheral Artery Disease, Atherosclerosis
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic
- Trial name
- RANGER II SFA (NCT03064126)
- Testing
- RANGER™ Paclitaxel Coated Balloon, Paclitaxel, Standard Balloon Angioplasty
- Where
- 67 sites in United States, Austria and 4 more
- Volunteers
- 440 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease, Peripheral Vascular Disease
Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vessel (HAV).
- Trial name
- NCT01872208
- Testing
- HAV implantation
- Where
- 3 sites in Poland
- Volunteers
- 20 people
- Sponsor
- Humacyte, Inc.
Peripheral Arterial Disease
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty
The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery…
- Trial name
- NCT04238546
- Testing
- sirolimus-coated balloon catheter, uncoated balloon catheter
- Where
- 2 sites in Switzerland
- Volunteers
- 1,200 people
- Sponsor
- Nils Kucher
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Peripheral Vascular Disease
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.
- Trial name
- PARADIGM (NCT01667393)
- Testing
- IDEV SUPERA Stent, Percutaneous Transluminal Angioplasty
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease…
- Trial name
- Remove (NCT04986098)
- Testing
- TurboHawk, Paclitaxel
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Soochow University
Arterial Disease, Atherosclerosis
Efficacy Between Different Two Self-Expanding Nitinol Stents For The Atherosclerotic Femoro-Popliteal Arterial Disease
Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment.
- Trial name
- SENS-FP (NCT01570803)
- Testing
- S.M.A.R.T CONTROL Stent, Complete SE Stent
- Where
- 2 sites in South Korea
- Sponsor
- Korea University Guro Hospital
Femoropopliteal Lesion
DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions
Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months.
- Trial name
- REBOOST (NCT06835660)
- Testing
- procedure of DCB implantation, procedure of SEDES implantation
- Where
- France
- Volunteers
- 402 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm
Venous Distension in Patients With Aneurysmatic Arterial Disease
The aim of the study is to assess if venous distension in patients with aneurysmatic arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD) and in controls.
- Conditions
- Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm, Peripheral Arterial Occlusive Disease, Vascular Diseases
- Trial name
- NCT02867501
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Kantonsspital Baselland Bruderholz
Restenosis, Peripheral Vascular Disease
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone.
- Trial name
- JetStreamISR (NCT01722877)
- Testing
- JetStream Navitus
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Popliteal Arterial Stenosis
Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease
More advanced and severe cases of chronic lower limb ischemia (the so-called critical lower limb ischemia) are painful and limiting conditions that impact on patients' quality of life.
- Trial name
- NCT05651165
- Testing
- Pharmacoactive balloon angioplasty. Lutonix®, Mimetic stent.Supera®
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Hospital Universitari de Bellvitge
Atherosclerosis of Native Arteries of the Extremities
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA)…
- Trial name
- IMPERIAL (NCT02574481)
- Testing
- ELUVIA (Stent Implantation), Zilver PTX (Stent Implantation)
- Where
- 68 sites in United States, Austria and 5 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
- Trial name
- NCT01616290
- Testing
- PRT-201
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Proteon Therapeutics
Chronic Limb Threatening Ischemia
Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of…
- Trial name
- NCT07120555
- Testing
- atherectomy, Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Peripheral Arterial Disease
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal…
- Trial name
- NCT02965677
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Where
- 13 sites in China
- Volunteers
- 172 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Atherosclerosis, In-stent Arterial Restenosis
Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
- Trial name
- NCT02832024
- Testing
- plaque excision system, stent, Balloon
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation