Clinical trials: Peripheral Arterial
Lumbar Spinal Stenosis, Intermittent Claudication
Investigating Superion™ In Spinal Stenosis
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of…
- Trial name
- NCT00692276
- Testing
- Superion™ Interspinous Spacer, X-STOP® IPD® Device
- Where
- 32 sites in United States
- Volunteers
- 391 people
- Sponsor
- Boston Scientific Corporation
Renal Artery Stenosis
A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months…
- Trial name
- GREAT (NCT00235157)
- Testing
- Sirolimus-eluting Palmaz Genesis peripheral stent
- Where
- 3 sites in France, Germany and 1 more
- Volunteers
- 105 people
- Sponsor
- Cordis US Corp.
Intermittent Claudication
Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of…
- Trial name
- NCT03864666
- Testing
- Cilostazol 100 mg, PMR 200 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Arterial Occlusive Diseases
The Study to Treat Superficial Femoral Artery Occlusions.
The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as…
- Trial name
- SUPER UK (NCT00232843)
- Testing
- stent, angioplasty
- Where
- 2 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- Cordis US Corp.
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.
Chronic Total Occlusion of Artery of the Extremities
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.
- Trial name
- CaTO-PAD (NCT05551780)
- Testing
- SoundBite Crossing System
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 130 people
- Sponsor
- SoundBite Medical Solutions, Inc.
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
Intermittent Claudication
Clinical Trial for GNX80 in Intermittent Claudication
This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.
- Trial name
- NCT05400395
- Testing
- GNX80
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- SK Chemicals Co., Ltd.
Arterial Disease of Legs, Below-the-knee Obstruction
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx.
- Conditions
- Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease
- Trial name
- MAGICAL BTK (NCT06182397)
- Testing
- MagicTouch PTA Sirolimus drug coated balloon
- Where
- 29 sites in United States
- Volunteers
- 368 people
- Sponsor
- Concept Medical Inc.
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.