Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Shockwave IVL + DES
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- Trial name
- Shockwave DES (NCT05291247)
- Testing
- Peripheral lithotripsy system (Shockwave Medical)
- Where
- 6 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Marc Bosiers, MD
Peripheral Arterial Disease (PAD)
Zilver® Flex™ Vascular Stent Study
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for…
- Trial name
- NCT00827619
- Testing
- Zilver® Flex™ Vascular Stent
- Where
- 3 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Cook Group Incorporated
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.
Femoral Artery Stenosis, Femoral Artery Occlusion
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Stenosis of Popliteal Arteries, Occlusion of Popliteal Arteries
- Trial name
- NCT02720003
- Testing
- LTX DCB
- Where
- 14 sites in China
- Volunteers
- 148 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
- Trial name
- NCT06938854
- Testing
- Peripheral Intravascular Lithotripsy (IVL)
- Where
- 10 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Shockwave Medical, Inc.
Arterial Occlusive Diseases, Vascular Diseases
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass.
- Trial name
- SPACIAL (NCT01147419)
- Testing
- stent, femoral-popliteal bypass with artificial blood vessel
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
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
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions
The T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and D femoropopliteal lesions.
- Trial name
- TINTIN (NCT03347383)
- Testing
- Combination therapy DCB + stent
- Where
- 9 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- ID3 Medical
Peripheral Artery Disease (PAD)
Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries
The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis…
- Trial name
- NCT04821388
- Testing
- Rontis DCB
- Where
- 5 sites in Greece
- Volunteers
- 30 people
- Sponsor
- Rontis Hellas SA
Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.
- Conditions
- Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia
- Trial name
- Framed IVB (NCT06082466)
- Testing
- FRAMED Infrainguinal Venous Bypass, Conventional Autologous Bypass
- Where
- Austria
- Volunteers
- 110 people
- Sponsor
- Paracelsus Medical University
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal…
- Trial name
- NCT07431437
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Femoropopliteal Artery Disease
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
Prospective, randomized, controlled, multi-center study A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
- Trial name
- NCT03517904
- Testing
- IVUS-guided angioplasty, Angiography-guided angioplasty
- Where
- South Korea
- Volunteers
- 237 people
- Sponsor
- Yonsei University
Femoropopliteal Occlusive Disease
The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
- Trial name
- NCT04698304
- Testing
- endovascular treatment
- Where
- China
- Volunteers
- 1,518 people
- Sponsor
- RenJi Hospital
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
- Trial name
- NCT05246410
- Testing
- Spot stent system, Self-expanding peripheral stent system
- Where
- 2 sites in China
- Volunteers
- 196 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Vascular Disease, Intermittent Claudication
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT00637741
- Testing
- Everflex 200
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Flanders Medical Research Program
Peripheral Vascular Diseases, Intermittent Claudication
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary…
- Conditions
- Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty
- Trial name
- NCT00715416
- Testing
- Nitinol stent, Nitinol Stent Placement
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Vienna General Hospital
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-eluting balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
Peripheral Arterial Disease
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
- Trial name
- SHIELD (NCT02568293)
- Testing
- SBCV, Saline
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 66 people
- Sponsor
- Symic Vascular
Peripheral Vascular Disease
Tack Optimized Balloon Angioplasty (TOBA) Study
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous…
- Trial name
- TOBA (NCT01663818)
- Testing
- Tack-It Endovascular Stapler
- Where
- Belgium
- Volunteers
- 138 people
- Sponsor
- Philips Clinical & Medical Affairs Global