Clinical trials: Infrainguinal Peripheral Artery Disease
Peripheral Vascular Disease
Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery…
- Trial name
- NCT02458911
- Testing
- Paclitaxel-eluting balloon
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- iVascular S.L.U.
Atherosclerosis, Peripheral Artery Disease
BIOLUX P-III All-Comers Passeo-18 Lux Registry
BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic…
- Trial name
- NCT02276313
- Testing
- Passeo-18 Lux
- Where
- 45 sites in Australia, Austria and 14 more
- Volunteers
- 880 people
- Sponsor
- Biotronik AG
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Angioplasty, Balloon, Disease, Peripheral Artery
Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the…
- Trial name
- NCT05175703
- Testing
- Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ajou University School of Medicine
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
Peripheral Arterial Disease, Critical Limb Ischemia
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial…
- Trial name
- NCT01609621
- Testing
- Retrograde tibiopedal arterial access
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 199 people
- Sponsor
- Cook Group Incorporated
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 Disease
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial…
- Trial name
- GREAT (NCT06321575)
- Testing
- Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
- Where
- 20 sites in United States
- Volunteers
- 159 people
- Sponsor
- Nipro Vascular Innovations Americas, Inc
Chronic Limb-Threatening Ischemia
Peripheral Bypass Trial for Completion Control
The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
- Trial name
- PATENT (NCT06264843)
- Testing
- MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Medistim ASA
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Artery Disease, Critical Limb Ischemia
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™)…
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication
- Trial name
- NCT02389023
- Testing
- standard gauze dressing, Prevena Incision Management system
- Where
- 5 sites in United States
- Volunteers
- 242 people
- Sponsor
- University of Vermont Medical Center
Infrainguinal Peripheral Arterial Disease
Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters.
- Trial name
- NCT02237066
- Testing
- Chocolate PTA Balloon Angioplasty, Standard PTA Balloon Angioplasty
- Where
- 2 sites in United States
- Sponsor
- TriReme Medical, LLC
Peripheral Arterial Disease
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
- Trial name
- NCT02653456
- Testing
- RA-308 Excimer Laser and DABRA Catheter
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ra Medical Systems
Critical Limb Ischemia
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.
- Trial name
- RIVAL-PAD (NCT02260622)
- Testing
- rivaroxaban plus aspirin, clopidogrel plus aspirin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Peripheral Arterial Disease
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease.
- Trial name
- MODIFY (NCT03268018)
- Testing
- Laser induced pressure wave calcium modification
- Where
- 2 sites in Belgium
- Volunteers
- 8 people
- Sponsor
- Spectranetics Corporation
Peripheral Vascular Disease
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia…
- Trial name
- NCT00067041
- Testing
- Remodulin (treprostinil sodium) Injection
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Peripheral Artery Disease, Atherosclerosis
Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in…
- Trial name
- XTOSI (NCT04368091)
- Testing
- Xtreme Touch - Neo sirolimus coated PTA balloon catheter
- Where
- Singapore
- Volunteers
- 50 people
- Sponsor
- Concept Medical Inc.
Peripheral Arterial Disease
Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands…
- Trial name
- BIO-OSCAR SOC (NCT05831319)
- Where
- 17 sites in Austria, Belgium and 6 more
- Volunteers
- 380 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease
Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in…
- Trial name
- NCT05999669
- Testing
- GLASS staging
- Volunteers
- 2,000 people
- Sponsor
- RenJi Hospital