Clinical trials: Femoropopliteal Artery Occlusion
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
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
- Trial name
- PQB4FP1 (NCT01930071)
- Testing
- PQ Bypass Guide Wire Delivery System
- Where
- New Zealand
- Volunteers
- 4 people
- Sponsor
- Endologix
Peripheral Arterial Disease
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients…
- Trial name
- NCT05868564
- Testing
- Atherectomy+Drug-coated balloon, Drug-coated balloon
- Where
- China
- Volunteers
- 100 people
- Sponsor
- RenJi Hospital
Peripheral Arterial Occlusive Disease, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
Peripheral Arterial Disease
REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions
A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.
- Trial name
- NCT02580955
- Testing
- LEGFLOW DCB
- Where
- 4 sites in Belgium
- Volunteers
- 120 people
- Sponsor
- Flanders Medical Research Program
Peripheral Arterial Disease (PAD)
Zilver Flex Post-Market Study in Japan
Japanese post market clinical study of the Zilver Flex device.
- Trial name
- NCT02254356
- Testing
- Zilver Flex Bare Metal Stent
- Where
- Japan
- Volunteers
- 239 people
- Sponsor
- Cook Group Incorporated
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
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 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
Restenosis, Peripheral Arterial Disease
Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
- Trial name
- PacTAP (NCT01599078)
- Testing
- Paclitaxel
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Femoropopliteal In-Stent Restenosis (ISR)
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment.
- Trial name
- NCT07277218
- Testing
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Volunteers
- 600 people
- Sponsor
- Chunshui He
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
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
Chronic Total Occlusion of Artery of the Extremities
Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions
This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs.
- Trial name
- FACTORY (NCT01268722)
- Testing
- Balloon angioplasty, Primary stenting
- Where
- 5 sites in Greece, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- University of Patras
Peripheral Arterial Disease
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard…
- Trial name
- CRACK-IT (NCT06112171)
- Testing
- Intravascular lithotripsy, Standard lesion preparation
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
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 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 Arterial Disease
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
- Trial name
- POWER-PAD-1 (NCT05192473)
- Testing
- Pulse Intravascular Lithotripsy System
- Where
- 3 sites in Australia, Dominican Republic and 1 more
- Volunteers
- 9 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease (PAD)
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Femoropopliteal Occlusive Disease, Below-the-knee Obstruction
- Trial name
- NCT03414515
- Testing
- Endovascular intervention
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed
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