Clinical trials: Peripheral Arterial Obstructive Disease
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers.
- Trial name
- CHASE (NCT06204237)
- Testing
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aplagon Oy
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Occlusive Disease
Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
- Trial name
- FINEST (NCT01113892)
- Testing
- vascular grafts
- Where
- 25 sites in United States, Czechia and 1 more
- Volunteers
- 207 people
- Sponsor
- Maquet Cardiovascular
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia
- Trial name
- MOBILE-CA (NCT02474121)
- Testing
- Bone marrow concentration device
- Where
- 9 sites in United States
- Sponsor
- Zimmer Biomet
Peripheral Arterial Disease (PAD)
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
- Trial name
- WISE-LE (NCT02780349)
- Testing
- WIRION
- Where
- 10 sites in United States, Germany
- Volunteers
- 103 people
- Sponsor
- Gardia Medical
Peripheral Arterial Disease
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.
- Trial name
- ATTAIN-PAD (NCT07223593)
- Testing
- Orforglipron
- Where
- 170 sites in United States, Argentina and 16 more
- Volunteers
- 1,205 people
- Sponsor
- Eli Lilly and Company
Peripheral Arterial Disease
The Jetstream G3™ Calcium Study
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
- Trial name
- NCT01273623
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in United States
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Iloprost Therapy in Patients With Critical Limb Ischemia
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
- Trial name
- NCT01458041
- Testing
- Iloprost (Ilomedin, BAYQ6256)
- Where
- Hungary
- Volunteers
- 126 people
- Sponsor
- Bayer
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Truway Diagnostic Tools in Primary Care
This study evaluates the effectiveness of Truway Health-sourced portable diagnostic devices, including ultrasound and blood glucose monitors, in early detection of chronic conditions in outpatient primary care settings.
- Conditions
- Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Hypertension, Cardiovascular Disease Acute
- Trial name
- TruDxPC (NCT07209527)
- Testing
- Truway Portable Ultrasound Device, Truway Blood Glucose Monitor, Standard Oral Hypoglycemic Agent
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Peripheral Artery Disease
ILLUMENATE Pivotal Post-Approval Study (PAS)
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate…
- Trial name
- NCT03421561
- Testing
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon, EverCross™ 0.035 PTA Balloon Catheter
- Where
- 41 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
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 Artery Disease
Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients
The purpose of this study is to evaluate whether PET/CT-RGD or MIBI can be used for the angiogenesis assessment of NL003 in PAD patients.
- Trial name
- NCT05968118
- Testing
- NL003
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
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 Artery Disease
Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries
The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
- Trial name
- NCT02953496
- Testing
- vonapanitase
- Where
- United States
- Sponsor
- Proteon Therapeutics
Arterial Occlusive Diseases
Crossing Atheroma or Thrombus With ByCross Device for Revascularization of Peripheral Arteries of Diameter ≥ 3mm
The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and Aspiration device used for revascularization of total or sub-total occluded peripheral arterial vessels equal to or larger than 3mm in…
- Trial name
- NCT03724279
- Testing
- ByCross Atherectomy and Thrombectomy
- Where
- 2 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Taryag Medical Ltd.
Peripheral Arterial Disease
An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform…
- Trial name
- REX (NCT02921542)
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease, Peripheral Vascular Disease
Atherectomy By Laser Ablation With Turbo-Elite
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
- Trial name
- ABLATE (NCT02307370)
- Testing
- Turbo-Elite Laser Catheter
- Volunteers
- 44 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation