Clinical trials: Chronic Limb Threatening Ischemia, active
Peripheral Artery Disease, Diabetes Mellitus
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical…
- Conditions
- Peripheral Artery Disease, Diabetes Mellitus, Chronic Limb-Threatening Ischemia
- Trial name
- NCT03622359
- Testing
- SPECT/CT perfusion imaging, PET/CT perfusion imaging
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Chronic Limb Threatening Ischemia
Vessel Recoil in Specific CLTI Populations
Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene.
- Trial name
- NCT07465627
- Testing
- Vessel recoil measurement 15 minutes post final treatment (angiographically)
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
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
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who…
- Conditions
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound, Major Adverse Limb Events
- Trial name
- CLARITY (NCT06979284)
- Testing
- IVUS-guided strategy
- Where
- 5 sites in Canada
- Volunteers
- 772 people
- Sponsor
- Hamilton Health Sciences Corporation
Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with…
- Trial name
- SISYPHUS (NCT07472049)
- Testing
- Whole body [68Ga]DOTATATE PET-CT, Whole body [18F]GP1 PET-CT, Whole body [18F]NaF PET-CT
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University of Edinburgh
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg.
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer, Infrapopliteal Arterial Occlusive Disease
- Trial name
- NCT07827521
- Testing
- Lower-Extremity Revascularization, Donaperminogene Seltoplasmid
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Chronic Total Occlusion of Artery of the Extremities
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond…
- Trial name
- NCT06492733
- Testing
- FastWire System - Peripheral
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Versono Medical Ltd
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural…
- Trial name
- CALCIO (NCT06149650)
- Testing
- Shockwave Medical IVL System
- Where
- 39 sites in Austria, Canada and 6 more
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Chronic Limb-Threatening Ischemia
IVUS Guidance in BTK Interventions
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb.
- Trial name
- IMAGE-BTK (NCT07731997)
- Testing
- Intravascular ultrasound-guided EVT, Angiography-guided EVT
- Where
- 4 sites in Taiwan
- Volunteers
- 212 people
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
Chronic Limb-Threatening Ischemia
Pivotal Trial of the Boomerang Catheter for pDVA
The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.
- Trial name
- NCT06311773
- Testing
- Boomerang Catheter
- Where
- 25 sites in United States
- Volunteers
- 120 people
- Sponsor
- Aveera Medical, Inc.
Chronic Limb-Threatening Ischemia
Colchicine in Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs.
- Trial name
- CIRCLE-Asia (NCT07536373)
- Testing
- Colchicine 0.5 MG Oral Tablet Once Daily
- Where
- 5 sites in Taiwan
- Volunteers
- 200 people
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
Peripheral Arterial Disease, Critical Limb Ischemia
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- TIC (NCT06544135)
- Testing
- FLIR One Pro LT
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- University Hospitals Cleveland Medical Center
Critical Limb Ischemia, Diabetes
Trial to Assess Chelation Therapy in Critical Limb Ischemia
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk…
- Trial name
- TACT3a (NCT03982693)
- Testing
- Edetate Disodium
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mt. Sinai Medical Center, Miami
Peripheral Arterial Disease, Aortoiliac Occlusive Disease
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia.
- Conditions
- Peripheral Arterial Disease, Aortoiliac Occlusive Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication
- Trial name
- PREMISE-ILIAC (NCT07672249)
- Testing
- Iliac stenting
- Where
- Italy
- Volunteers
- 98 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio