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.
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
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
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
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 Artery Disease
Soundbite Crossing System Peripheral First in Man
This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire…
- Trial name
- NCT03013088
- Testing
- CTO Crossing
- Where
- 2 sites in Canada
- Volunteers
- 37 people
- Sponsor
- SoundBite Medical Solutions, Inc.
Peripheral Vascular Disease
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.
- Trial name
- ENDURE (NCT02129127)
- Testing
- Paclitaxel Coated Chocolate Balloon Angioplasty
- Where
- 2 sites in Germany, New Zealand
- Volunteers
- 67 people
- Sponsor
- TriReme Medical, LLC