Clinical trials: Peripheral Arterial Occlusive Disease
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
Aortic Disorders, Carotid Disease
A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)
This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the…
- Conditions
- Aortic Disorders, Carotid Disease, Pulmonary Disease, Peripheral Artery Disease
- Trial name
- Iomeron®-400 (NCT02596048)
- Testing
- Iomeron
- Where
- 5 sites in China
- Volunteers
- 224 people
- Sponsor
- Bracco Diagnostics, Inc
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease
Effect of Neo40 on PAD
Reduced nitric oxide (NO) availability is a hallmark of a number of cardiovascular diseases (CVD) including peripheral artery disease (PAD).
- Trial name
- NCT02934438
- Testing
- Neo40
- Volunteers
- 30 people
- Sponsor
- HumanN
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 Arterial Disease
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.
- Trial name
- RAPID II (NCT02742077)
- Testing
- Robotic-assisted peripheral vascular intervention
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
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 Vascular Diseases
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based…
- Trial name
- NCT01558908
- Testing
- Administration of ERC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Medistem Inc.
Peripheral Arterial Disease, Femoropopliteal Stenosis
PMCF Study for Peripheral Arteries Above the Knee (ATK)
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the…
- Conditions
- Peripheral Arterial Disease, Femoropopliteal Stenosis, Angiopathy, Peripheral
- Trial name
- NCT05312580
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 387 people
- Sponsor
- Cordis US Corp.
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 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
Diabetes, Peripheral Arterial Disease
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD).
- Trial name
- NCT02145988
- Testing
- DLBS1033
- Where
- 2 sites in Indonesia
- Volunteers
- 11 people
- Sponsor
- Dexa Medica Group
Peripheral Artery Disease, Femoropopliteal Artery Disease
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.
- Trial name
- PAX (NCT02145065)
- Testing
- Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland), Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
- Where
- Poland
- Volunteers
- 66 people
- Sponsor
- Balton Sp.zo.o.
Peripheral Arterial Occlusive Disease
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD)…
- Trial name
- NCT01157156
- Testing
- XRP0038 (NV1FGF)
- Where
- 2 sites in United States, Finland
- Volunteers
- 51 people
- Sponsor
- Sanofi
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
Intermittent Claudication, Peripheral Vascular Disease
Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a…
- Conditions
- Intermittent Claudication, Peripheral Vascular Disease, Atherosclerosis
- Trial name
- WALK (NCT00117650)
- Testing
- Ad2/HIF-1α/VP16
- Where
- 47 sites in United States, Germany and 1 more
- Volunteers
- 289 people
- Sponsor
- Genzyme, a Sanofi Company
Peripheral Arterial Disease, Intermittent Claudication
Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System
The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD).
- Trial name
- REALITY III (NCT03071146)
- Testing
- Bard® LifeStent® 5F Vascular Stent System
- Where
- 4 sites in Germany
- Volunteers
- 30 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff…
- Trial name
- COMPAR-MI (NCT04709991)
- Testing
- Endovascular procedure
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Therenva
Peripheral Arterial Disease
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
- Trial name
- NCT04241224
- Testing
- Atherectomy
- Where
- 10 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ra Medical Systems
Peripheral Artery Disease
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform.
- Trial name
- NCT04514861
- Testing
- Wireless Lumee Oxygen Platform
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Profusa, Inc.