Clinical trials: Femoropopliteal Disease
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
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
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
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 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
Atherosclerosis, Vascular Disease
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
- Conditions
- Atherosclerosis, Vascular Disease, Arteriosclerosis
- Trial name
- LEVANT I (NCT00930813)
- Testing
- Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 101 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
Edoxaban in Peripheral Arterial Disease
This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential…
- Trial name
- ePAD (NCT01802775)
- Testing
- edoxaban, Clopidogrel, Aspirin
- Where
- 42 sites in United States, Austria and 5 more
- Volunteers
- 203 people
- Sponsor
- Daiichi Sankyo
Peripheral Arterial Disease
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon…
- Trial name
- RADIANCY (NCT05399680)
- Testing
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Where
- 12 sites in Austria, Belgium and 4 more
- Volunteers
- 151 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease
Chronic Total Occlusion Crossing With the Wildcat Catheter
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO).
- Trial name
- CONNECT (NCT01174784)
- Testing
- Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
- Where
- 15 sites in United States
- Volunteers
- 88 people
- Sponsor
- Avinger, Inc.
Peripheral Vascular Disease
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex…
- Trial name
- NCT03206762
- Testing
- Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Midwest Cardiovascular Research Foundation
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
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
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 Arterial Disease, Peripheral Vascular Disease
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
- Trial name
- TRANSCEND (NCT03241459)
- Testing
- Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 446 people
- Sponsor
- SurModics, Inc.
Peripheral Artery Disease
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
- Trial name
- NCT01628159
- Testing
- Lutonix Drug Coated Balloon
- Where
- 64 sites in United States, Austria and 3 more
- Volunteers
- 657 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
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
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
- Trial name
- DETOUR1 (NCT02471638)
- Testing
- PQ Bypass System for Femoropopliteal Bypass
- Where
- 8 sites in Chile, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- Endologix
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
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