Clinical trials: Angiopathy, Peripheral, open to volunteers
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Diabetic Foot, Diabetes Mellitus
Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness ("immediate" treatment, within 48h) has advantages…
- Conditions
- Diabetic Foot, Diabetes Mellitus, Peripheral Arterial Disease, Diabetic Neuropathies
- Trial name
- PTA-DFS (NCT06124586)
- Testing
- Percutaneous transluminal angioplasty
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aerobic Physical Exercise, Traditional Strength Exercise
Acute Effects of Exercise in Peripheral Arterial Disease Patients
Peripheral arterial disease (PAD) affects over 200 million people worldwide and is caused by narrowing of the arteries. Intermittent claudication, characterized by pain when walking, is its main symptom.
- Conditions
- Aerobic Physical Exercise, Traditional Strength Exercise, Circuit Strength Exercise, Control
- Trial name
- VESSEL-FIT (NCT07248137)
- Testing
- Aerobic exercise, Traditional strength exercise, Circuit strength exercise
- Volunteers
- 16 people
- Sponsor
- European University Miguel de Cervantes
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular…
- Trial name
- NCT06899113
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MIMOSA Diagnostics Inc.
Critical Limb Ischemia (CLI)
Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry
To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal…
- Trial name
- CLEAR TOE (NCT07014072)
- Testing
- intensive toe pressure evaluation, data collection
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bordeaux
Peripheral Arterial Disease
Local or Systemic Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD
INTRODUCTION: Exercise with an arm ergometer (EB) overcomes the main barrier to physical exercise in patients with Peripheral Artery Disease (PAD), leg pain during walking.
- Trial name
- NCT06828172
- Testing
- Exercise
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Nove de Julho
Aorta Disease, Peripheral Artery Disease
Asan Aorta and Peripheral Registry
The purpose of this study is to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at Asan Medical Center.
- Trial name
- PTA (NCT06022653)
- Testing
- Treatment
- Where
- South Korea
- Volunteers
- 6,000 people
- Sponsor
- Asan Medical Center
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 Arterial Disease
Prehabilitation and Rehabilitation in PAD
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
- Trial name
- PREPARE-IT (NCT06566976)
- Testing
- Exercise Intervention, VAPAHCS Rehabilitation Core Components
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Palo Alto Veterans Institute for Research
Arthroplasty Complications, Muscle Weakness
Achilles Tendon for the Treatment of Gluteus Medius Insufficiency
Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical…
- Conditions
- Arthroplasty Complications, Muscle Weakness, Muscle Atrophy, Muscle Tear
- Trial name
- HLS (NCT05206838)
- Testing
- Surgical reconstruction of gluteus medius with Achilles tendon allograft
- Where
- Sweden
- Volunteers
- 44 people
- Sponsor
- Sahlgrenska University Hospital
Peripheral Artery Disease (PAD)
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries.
- Trial name
- SELECT (NCT06605209)
- Testing
- Peripheral Balloon-Expandable Covered Stent System
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Critical Limb Ischemia, Malnutrition
Nutrition in Patient With Critical Limb Ischemia
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from…
- Conditions
- Critical Limb Ischemia, Malnutrition, Nutritional Supplements
- Trial name
- NutriVasc (NCT03529019)
- Testing
- Ensure Surgery Immunonutrition Shake, Ensure Enlive Advanced Nutrition Shake
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Medical Center
Peripheral Arterial Disease
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard…
- Trial name
- CRACK-IT (NCT06112171)
- Testing
- Intravascular lithotripsy, Standard lesion preparation
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Peripheral Artery Disease
Leg Heat Therapy in Peripheral Artery Disease
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from…
- Trial name
- NCT05465070
- Testing
- Leg heat therapy
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Indiana University
Systemic Sclerosis (SSc)
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial.
- Trial name
- ASScERT-QoL (NCT06675344)
- Testing
- Apollo Neuro Device
- Where
- 4 sites in United States
- Volunteers
- 160 people
- Sponsor
- Robyn T. Domsic, MD, MPH
Peripheral Arterial Disease (PAD), Ankle Brachial Index
Automated ABPI in Peripheral Arterial Disease a Pilot Study
The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the…
- Conditions
- Peripheral Arterial Disease (PAD), Ankle Brachial Index, Diagnostic Accuracy, Feasibility Studies
- Trial name
- AUTO-PAD (NCT07850349)
- Testing
- MESI mTablet, BlueDop vascular Expert (BlueDopVE)
- Where
- United Kingdom
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Hull University Teaching Hospitals NHS Trust
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.
Peripheral Arterial Disease
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion.
- Trial name
- NCT07049120
- Testing
- ZENFLEX Pro™ Peripheral Drug-eluting Stent System
- Where
- Poland
- Volunteers
- 153 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Critical Ischemia Limb
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Peripheral arteriopathy disease (PAD) affects 1 million people in France. In its most advanced stage: chronic permanent ischemia also called critical ischemia, the prognosis of patients is burdened with a one-year mortality rate…
- Trial name
- NOBILIS (NCT06238050)
- Testing
- introduction of oxygen therapy or not
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Angers
Sarcopenia, Body Composition
CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease
Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking.
- Conditions
- Sarcopenia, Body Composition, Sarcopenic Obesity, Peripheral Arterial Disease
- Trial name
- COMPOSE-PAD (NCT07433309)
- Testing
- SET physiotherapy, CT scan
- Volunteers
- 128 people
- Sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.