Clinical trials: Femoropopliteal Stenosis
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
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Femoropopliteal Artery Stenoses or Occlusive Lesions
A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
- Trial name
- NCT07187128
- Testing
- drug coating balloon angioplasty
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- BrosMed Medical Co., Ltd
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
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
Peripheral Artery Disease, Femoropopliteal Artery Occlusion
LEVANT 2 Safety Registry
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT01790243
- Testing
- Lutonix Drug Coated Balloon, Standard PTA Balloon
- Where
- 8 sites in United States
- Volunteers
- 1,189 people
- Sponsor
- C. R. Bard
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 Artery Disease, Femoropopliteal Artery Stenosis
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- Trial name
- STRONG (NCT01154751)
- Testing
- SUPERA Interwoven self-expanding nitinol stent
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Femoropopliteal Stenosis
PMCF Study for Peripheral Arteries Above the Knee (ATK)
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the…
- Conditions
- Peripheral Arterial Disease, Femoropopliteal Stenosis, Angiopathy, Peripheral
- Trial name
- NCT05312580
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 387 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease (PAD)
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
- Trial name
- XPEDITE (NCT02936622)
- Testing
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating, Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- Where
- 11 sites in Germany, New Zealand
- Volunteers
- 176 people
- Sponsor
- Cook Group Incorporated
Femoral Artery Stenosis, Popliteal Artery Stenosis
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries
The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- LEVANT 2 (NCT01412541)
- Testing
- Standard Uncoated Angioplasty Balloon, Moxy Drug Coated Balloon
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 532 people
- Sponsor
- C. R. Bard
Atherosclerosis, Arteriosclerosis
BIOLUX P-I First in Man Study
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs.
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- NCT01221610
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 60 people
- Sponsor
- Biotronik AG
Femoral Artery Occlusion, Femoral Arterial Stenosis
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
- Trial name
- NCT02013271
- Testing
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Where
- 14 sites in Austria, Belgium and 3 more
- Volunteers
- 125 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
- Trial name
- NCT04982367
- Testing
- Sirolimus-eluting balloon catheter, Paclitaxel-eluting balloon catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Acotec Scientific Co., Ltd
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™…
- Conditions
- Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- REAL-SMART (NCT07338890)
- Testing
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Cordis US Corp.
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
- 38 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
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 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
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 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.