Clinical trials: Peripheral Arterial
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, Intermittent Claudication
High Intensity Interval Training In pATiEnts With Intermittent Claudication
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
- Trial name
- INITIATE (NCT04042311)
- Testing
- High-intensity interval training
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Coronary Artery Disease
Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine
Ticagrelor is associated with more prompt and potent antiplatelet effects compared with clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality, across the spectrum of patients with acute…
- Trial name
- NCT02403830
- Testing
- Methylnaltrexone, Morphine, Ticagrelor
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Peripheral Artery Occlusion, Peripheral Arterial Disease
AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.
- Trial name
- RESTOR-1 (NCT04663867)
- Testing
- AngioSafe Peripheral CTO Crossing System
- Where
- 18 sites in United States
- Volunteers
- 79 people
- Sponsor
- AngioSafe, Inc.
Peripheral Artery Disease, Peripheral Vascular Disease
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Arterial Occlusive Disease
- Trial name
- BOLSTER (NCT02228564)
- Testing
- Percutaneous transluminal angioplasty (PTA), LIFESTREAM™ covered stent
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 155 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
- Trial name
- DETOUR1 (NCT02471638)
- Testing
- PQ Bypass System for Femoropopliteal Bypass
- Where
- 8 sites in Chile, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- Endologix
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Peripheral Arterial Occlusive Disease
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
- Trial name
- NCT00740207
- Testing
- VISIPAQUE 270, Isovue 250
- Volunteers
- 33 people
- Sponsor
- Bracco Diagnostics, Inc
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Peripheral Arterial Disease
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with…
- Trial name
- STERILE (NCT00914316)
- Testing
- Ranolazine
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Corewell Health East
Coronary Artery Disease, Atherosclerosis
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy
The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Stent Placement
- Trial name
- SYNIVUS-DAPT (NCT03606642)
- Testing
- Dual Antiplatelet (DAPT) Therapy, The Synergy® stent
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- HonorHealth Research Institute
Intracranial Aneurysms, Peripheral Aneurysms
Study of the Penumbra Coil 400 System to Treat Aneurysm
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System.
- Trial name
- ACE (NCT01465841)
- Testing
- PC 400 coils (Penumbra )
- Where
- 6 sites in United States
- Volunteers
- 517 people
- Sponsor
- Penumbra Inc.
Intermittent Claudication, Peripheral Vascular Diseases
Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?
Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the management of patients with IC…
- Trial name
- NESIC (NCT03446027)
- Testing
- NMES
- Where
- 11 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Imperial College London
Peripheral Arterial Occlusion or Emboli
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or…
- Trial name
- PRISM (NCT02085551)
- Testing
- Mechanical Thrombectomy by the Indigo System
- Where
- 5 sites in United States
- Volunteers
- 85 people
- Sponsor
- Penumbra Inc.
Peripheral Artery Disease, Femoropopliteal Artery Stenosis
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- Trial name
- STRONG (NCT01154751)
- Testing
- SUPERA Interwoven self-expanding nitinol stent
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Intermittent Claudication
A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
The goal of the proposed pilot study is to evaluate the feasibility of a new leg heat therapy system treatment for patients with lower extremity PAD.
- Trial name
- NCT05335161
- Testing
- Home-based leg heat therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Purdue University
Peripheral Artery Disease
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality…
- Trial name
- OPTIMISE (NCT01743872)
- Testing
- Contrast Injection, Dextran Injection, CO2 Injection
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Peripheral Arterial Disease, Lower Extremity Arterial Disease
EverFlex Post Approval Study
This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal…
- Trial name
- DURABILITY PAS (NCT01680835)
- Testing
- EverFlex™ Self-Expanding Peripheral Stent System
- Where
- 23 sites in United States
- Volunteers
- 108 people
- Sponsor
- Medtronic Endovascular
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.