Clinical trials: Peripheral Arterial Obstructive Disease
Peripheral Arterial Disease
ChampioNIR® SFA Stent EFS Study
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease
- Trial name
- NCT03775226
- Testing
- ChampioNIR® SFA Stent
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- Medinol Ltd.
Peripheral Arterial Disease
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity…
- Trial name
- COMBINE-II (NCT02126540)
- Testing
- Pantheris Atherectomy System
- Where
- New Zealand
- Sponsor
- Avinger, Inc.
Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A…
- Trial name
- TOBA II (NCT02522884)
- Testing
- Tack Endovascular System
- Where
- 39 sites in United States, Austria and 1 more
- Volunteers
- 213 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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 Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup
Post market clinical follow up of Bycross® device.
- Trial name
- NCT05110079
- Testing
- ByCross Atherectomy and Thrombectomy
- Where
- 3 sites in Germany
- Volunteers
- 75 people
- Sponsor
- Taryag Medical Ltd.
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
Peripheral Artery Disease
Prospective, Post Market Surveillance Q3-registry (POLARIS)
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System
- Trial name
- Q3-Registry (NCT02307292)
- Testing
- POLARIS Peripheral Vascular Self Expanding Stent System
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Peripheral Arterial Disease
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
The purpose of this study is to evaluate the safety and efficacy of interlocking detachable coils system in the treatment of Chinese patients with embolization of peripheral arterial in comparison with Interlock Fibered IDC…
- Trial name
- NCT05391399
- Testing
- Interlocking detachable coils system, Interlock Fibered IDC Occlusion System
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
Critical Limb Ischemia, Peripheral Vascular Disease
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased…
- Trial name
- mesendo (NCT00518401)
- Testing
- Mesendo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the…
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- EnEPC-CLI (NCT02805023)
- Testing
- BGC101 (autologous EnEPC preparation), Control medium
- Where
- 5 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- BioGenCell Ltd.
Critical Limb Ischemia
Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease
Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an emerging treatment modality for no-option patients with peripheral artery disease (PAD).
- Trial name
- NCT01584986
- Testing
- ACP injections
- Where
- 2 sites in Hungary
- Volunteers
- 22 people
- Sponsor
- Salus Ltd.
Prevention & Control
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
The primary objectives of this study are: To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction…
- Trial name
- COMPASS (NCT01776424)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Aspirin, Pantoprazole
- Where
- 565 sites in United States, Argentina and 31 more
- Volunteers
- 27,395 people
- Sponsor
- Bayer
Critical Limb Ischemia
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia.
- Trial name
- NCT00696124
- Testing
- VM202 2 mg, VM202 4 mg, VM202 8 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Diabetes Mellitus Type 2, Cardiovascular Diseases
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
- Conditions
- Diabetes Mellitus Type 2, Cardiovascular Diseases, Coronary Artery Disease, Cerebrovascular Disease
- Trial name
- PRIZETAG (NCT06567795)
- Testing
- Hemotag
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Aventusoft, LLC.
Peripheral Arterial Disease
Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
The primary aim of this trial was to investigate the safety of a 6 hour intraarterial infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive disease (PAOD) and chronic Critical Limb Ischaemia…
- Trial name
- COINART-1 (NCT02215824)
- Testing
- BIWH 3
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Peripheral Arterial Disease
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT07472439)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Volunteers
- 50 people
- Sponsor
- Angiodynamics, Inc.
Peripheral Arterial Disease
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites.
- Trial name
- FAST (NCT03365154)
- Testing
- Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment, Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cardio Flow, Inc.
Atherosclerosis, Arteriosclerosis
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of…
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- BIOLUX P-II (NCT01867736)
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 72 people
- Sponsor
- Biotronik AG