Clinical trials: Peripheral Arterial
Peripheral Vascular Disease
SAMBA EU Femoropopliteal Trial
The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.
- Trial name
- NCT01139177
- Testing
- Stenting of atherosclerotic lesion(s)
- Where
- 2 sites in Germany
- Volunteers
- 39 people
- Sponsor
- NovoStent Corporation
Peripheral Artery Disease
A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.
- Trial name
- REALITY2 (NCT02262949)
- Testing
- LifeStent Vascular Stent
- Where
- 4 sites in Germany
- Volunteers
- 31 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
- Trial name
- NCT05415995
- Testing
- Drug eluting Balloon
- Where
- 20 sites in China
- Volunteers
- 202 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
Peripheral Arterial Disease
Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
This is a BlueDop Vascular Expert System (BVE) Post-Market Clinical Follow-Up (PMCF) study. The primary objective of the study is to assess the clinical applicability and diagnostic accuracy of the BVE device in subjects who…
- Trial name
- NCT05073510
- Testing
- BVE
- Where
- 4 sites in Spain
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- BlueDop Medical LTD
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Peripheral Arterial Disease
Advance® 18PTX® Balloon Catheter Study
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.
- Trial name
- NCT00776906
- Testing
- Advance® 18PTX® Balloon Catheter, Advance® 18LP Balloon Catheter
- Where
- 4 sites in Germany, Russia
- Volunteers
- 150 people
- Sponsor
- Cook Group Incorporated
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)
To evaluate the safety and efficacy of recombinant human hepatocyte growth factor (HGF) bare plasmid injection for local intramuscular injection in the treatment of patients with severe lower limb hemorrhagic disease (Rutherford…
- Conditions
- Arterial Occlusive Disease, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04275323
- Testing
- NL003, Normal Saline
- Where
- 13 sites in China
- Volunteers
- 302 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Angioplasty, Peripheral Arterial Disease
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions.
- Conditions
- Angioplasty, Peripheral Arterial Disease, Drug-eluting Balloon, Femoral Artery
- Trial name
- LUMIFOLLOW (NCT04743180)
- Testing
- LUMINOR© Paclitaxel eluting balloon
- Where
- 15 sites in France
- Volunteers
- 500 people
- Sponsor
- iVascular S.L.U.
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Peripheral Arterial Disease
Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment
The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.
- Trial name
- NCT02556255
- Testing
- B-Laser™ Atherectomy Catheter
- Where
- 2 sites in Poland
- Volunteers
- 57 people
- Sponsor
- Eximo Medical Ltd.
Critical Limb Ischemia
Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- PROMISE UK (NCT03807661)
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 6 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- LimFlow SA
Peripheral Arterial Disease
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive…
- Trial name
- TALISMAN 201 (NCT00368797)
- Testing
- XRP0038 (NV1FGF)
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 125 people
- Sponsor
- Sanofi
Critical Limb Ischemia
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
Arterial Occlusive Diseases
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Primary objective: To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee…
- Trial name
- NCT00174759
- Testing
- Clopidogrel
- Where
- 14 sites in Australia, Austria and 12 more
- Volunteers
- 1,460 people
- Sponsor
- Sanofi
Hypercholesterolemia
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
- Trial name
- V-DIFFERENCE (NCT05192941)
- Testing
- Inclisiran Sodium
- Where
- 136 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 1,770 people
- Sponsor
- Novartis Pharmaceuticals
Peripheral Arterial Disease
BIOLUX P-III SPAIN All-Comers Registry
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily…
- Trial name
- NCT03052296
- Testing
- Passeo-18 Lux DCB
- Where
- 5 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Biotronik AG
Embolization, Therapeutic
Caterpillar™ Arterial Embolization Device Post-Market Study
The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label…
- Trial name
- MONARCH (NCT04244370)
- Testing
- Caterpillar™ Arterial Embolization Device
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- C. R. Bard
Critical Limb Ischemia, Peripheral Arterial Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd