Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due…
- Trial name
- PREVEIL (NCT02648620)
- Testing
- SurVeil Drug Coated Balloon, Angioplasty
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- SurModics, Inc.
Peripheral Vascular Disease
SAMBA EU Femoropopliteal Trial
The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.
- Trial name
- NCT01139177
- Testing
- Stenting of atherosclerotic lesion(s)
- Where
- 2 sites in Germany
- Volunteers
- 39 people
- Sponsor
- NovoStent Corporation
Peripheral Arterial Disease
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of…
- Trial name
- TAP-DANCE (NCT03942601)
- Testing
- Temsirolimus, Temsirolimus and dexamethasone sodium phosphate
- Where
- 11 sites in United States
- Volunteers
- 10 people
- Sponsor
- Mercator MedSystems, Inc.
PTA (Percutaneous Transluminal Angioplasty ), Femoropopliteal Artery Disease
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.
- Trial name
- GENOSS PCB (NCT07399080)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Genoss Co., Ltd.
Peripheral Arterial Disease, Stenosis
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular…
- Conditions
- Peripheral Arterial Disease, Stenosis, Dissection
- Trial name
- SURF (NCT06539689)
- Testing
- Sperstent® peripheral spot stent system, Everflex® self-expanding peripheral stent system
- Where
- 12 sites in China
- Volunteers
- 240 people
- Sponsor
- FrontAce Scientific Co., Ltd
Peripheral Arterial Disease
TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
- Trial name
- NCT03306199
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Superficial Femoral Artery Disease, Popliteal Artery Disease
Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease
The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.
- Trial name
- PRIZER (NCT04546477)
- Testing
- Stent implantation
- Where
- 13 sites in Belgium, France and 3 more
- Volunteers
- 135 people
- Sponsor
- Terumo Europe N.V.
Peripheral Vascular Diseases
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7…
- Trial name
- Zilver PTX (NCT00120406)
- Testing
- Zilver® PTX™ Drug Eluting Vascular Stent, Angioplasty
- Where
- 52 sites in United States, Germany and 1 more
- Volunteers
- 474 people
- Sponsor
- Cook Group Incorporated
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 Diseases
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically…
- Trial name
- DANCE (NCT01983449)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP
- Where
- 38 sites in United States
- Volunteers
- 285 people
- Sponsor
- Mercator MedSystems, 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, Peripheral Vascular Disease
Zilver® PTX™ Global Registry
The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of…
- Trial name
- NCT01094678
- Testing
- Zilver® PTX™ Stent
- Where
- 4 sites in Germany, Italy
- Volunteers
- 788 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal…
- Trial name
- MIMICS-2 (NCT02400905)
- Testing
- BioMimics 3D Vascular Stent System
- Where
- 43 sites in United States, Germany and 1 more
- Volunteers
- 271 people
- Sponsor
- Veryan Medical Ltd.
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.
Peripheral Artery Disease, Peripheral Vascular Disease
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases
- Trial name
- OPEN (NCT01355406)
- Testing
- FlexStent® Femoropopliteal Self Expanding Stent System
- Where
- 38 sites in United States, Belgium
- Volunteers
- 257 people
- Sponsor
- Cordis US Corp.
Arterial Occlusive Diseases, Atherosclerosis
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions…
- Conditions
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
- Trial name
- REGAL (NCT03037411)
- Testing
- Peripheral stenting
- Where
- 23 sites in Austria, Belgium and 3 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
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 Artery Disease
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system（G-stream） in the treatment of femoropopliteal artery stenosis or occlusion.
- Trial name
- G-streamPAD (NCT05780359)
- Testing
- Drug eluting stent, drug coating balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
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.
Peripheral Arterial Disease
BIOLUX P-III SPAIN All-Comers Registry
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily…
- Trial name
- NCT03052296
- Testing
- Passeo-18 Lux DCB
- Where
- 5 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Biotronik AG