Clinical trials: Peripheral Arterial Disease
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Peripheral Arterial Disease
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione.
- Trial name
- CLAUDIA (NCT06774040)
- Testing
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- VivaCell Biotechnology España
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
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Peripheral Arterial Disease, Vascular Disease, Peripheral
Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System
Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.
- Trial name
- Disrupt PAD+ (NCT04585763)
- Testing
- Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 37 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease
BEnefit of Arterial Preparation by LONGitudinal Scoring
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
- Trial name
- BELONG (NCT03721939)
- Testing
- FLEX Scoring Catheter
- Where
- Switzerland
- Volunteers
- 150 people
- Sponsor
- VentureMed Group Inc.
Arterial Occlusive Diseases
A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO).
- Trial name
- PRIORITY (NCT00418483)
- Testing
- Plasmin (Human) 25 mg, Plasmin (Human) 50 mg, Plasmin (Human) 75 mg
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Grifols Therapeutics LLC
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
Symptomatic Vascular Disease of the Iliac Arteries
FORMAT Clinical Study
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
- Trial name
- NCT01804088
- Testing
- Formula™ 535 Iliac Balloon-Expandable Stent
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
Peripheral Vascular Disease
Tack Optimized Balloon Angioplasty (TOBA) Study
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous…
- Trial name
- TOBA (NCT01663818)
- Testing
- Tack-It Endovascular Stapler
- Where
- Belgium
- Volunteers
- 138 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atherosclerosis
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels
- Trial name
- NCT00847782
- Testing
- Blood draw
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Peripheral Arterial Disease, Iliac Artery Stenosis
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- NCT03844724
- Testing
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Volunteers
- 204 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
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
Peripheral Artery Disease
ACOART BTK RENEW：A Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee…
- Trial name
- NCT04885985
- Testing
- DEB catheter
- Where
- China
- Volunteers
- 107 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Arterial Disease
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial…
- Trial name
- PLC (NCT00809497)
- Testing
- Propionyl-L-carnitine Tablets
- Where
- China
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Peripheral Artery Disease
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
- Trial name
- NCT02137577
- Testing
- DEB catheter, common PTA balloon catheter
- Where
- 11 sites in China
- Volunteers
- 120 people
- Sponsor
- Acotec Scientific Co., Ltd
Aneurysm Abdominal, Peripheral Aneurysms
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery…
- Conditions
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis
- Trial name
- NCT05519826
- Testing
- Vascular surgery
- Where
- France
- Volunteers
- 373 people
- Sponsor
- Perouse Medical
Peripheral Artery Disease
A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)
The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent
- Trial name
- REALITY (NCT01920308)
- Testing
- 5 mm Bard LifeStent Vascular Stent
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- C. R. Bard