Clinical trials: Peripheral Artery Diseases
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Peripheral Vascular Diseases, Coronary Artery Disease
Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire
The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal…
- Trial name
- SPOMCIDGW (NCT06735846)
- Testing
- Guide wire
- Volunteers
- 100 people
- Sponsor
- DemaxGroup
Critical Limb Ischemia, Peripheral Artery Disease
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
- Trial name
- NCT04304105
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 192 people
- Sponsor
- LimFlow, Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
Peripheral Arterial Disease, Arterio-venous Fistula
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or…
- Conditions
- Peripheral Arterial Disease, Arterio-venous Fistula, Arteriovenous Graft
- Trial name
- NCT03538392
- Testing
- Serranator® Alto
- Sponsor
- Cagent Vascular LLC
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT03847233
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease (PAD)
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- UltraFuture I (NCT05498740)
- Testing
- Drug eluting Balloon
- Where
- 24 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Peripheral Vascular Diseases
A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease
The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty).
- Trial name
- NCT01183117
- Testing
- SM-01, PTA
- Where
- Japan
- Volunteers
- 105 people
- Sponsor
- Johnson & Johnson K.K. Medical Company
Peripheral Artery Disease (PAD)
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries.
- Trial name
- SELECT (NCT06605209)
- Testing
- Peripheral Balloon-Expandable Covered Stent System
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Artery Disease, Peripheral Vascular Disease
The VaSecure BTK Study
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease
- Trial name
- NCT03638115
- Testing
- VaSecure™
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 46 people
- Sponsor
- Vascuros Medical Pte Ltd
Peripheral Arterial Vascular Disease
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice.
- Trial name
- NCT00854516
- Testing
- A new treatment approach is to have an effective working pressure combined with a low resting pressure.
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Solventum US LLC
Peripheral Artery Disease, Atherosclerosis
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic
- Trial name
- RANGER II SFA (NCT03064126)
- Testing
- RANGER™ Paclitaxel Coated Balloon, Paclitaxel, Standard Balloon Angioplasty
- Where
- 67 sites in United States, Austria and 4 more
- Volunteers
- 440 people
- Sponsor
- Boston Scientific Corporation
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
- Trial name
- MIMICS-3D (NCT02900924)
- Testing
- BioMimics 3D Stent
- Where
- 23 sites in Belgium, Germany and 2 more
- Volunteers
- 507 people
- Sponsor
- Veryan Medical Ltd.
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
- Trial name
- NCT05246410
- Testing
- Spot stent system, Self-expanding peripheral stent system
- Where
- 2 sites in China
- Volunteers
- 196 people
- Sponsor
- Acotec Scientific Co., Ltd