Clinical trials: Limb Ischemia, Critical
Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the…
- Trial name
- XCELL (NCT00515346)
- Testing
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VIVA Physicians
Peripheral Arterial Disease, Critical Limb Ischemia
Serranator Recoil Study
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as…
- Trial name
- NCT05161039
- Testing
- Serranator, POBA
- Where
- 2 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Cagent Vascular LLC
Chronic Limb Threatening Ischaemia
Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
17, 000 people every year in the UK develop foot pain or wounds from blocked leg arteries. If left untreated, this can lead to amputation.
- Trial name
- DUSTER (NCT06702306)
- Testing
- Ultrasound Surveillance
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Mid and South Essex NHS Foundation Trust
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
Chronic Limb Threatening Ischemia
Referrals for CLTI: Qualitative Study
The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI).
- Trial name
- NCT05659004
- Testing
- Qualitative interview
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- University of Hull
Peripheral Arterial Disease, Critical Limb Ischaemia
Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
- Trial name
- NCT02634138
- Testing
- Revitive IX
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Imperial College London
Peripheral Arterial Disease, Venous Thormboembolism
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures.
- Conditions
- Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases, Vascular Surgery Patient with PAD / Carotid Stenosis
- Trial name
- RESOLUTION (NCT06873321)
- Testing
- rivaroxaban 2.5 mg bid + aspirin 100 mg, clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Science Valley Research Institute
Peripheral Arterial Disease, Angioplasty
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in…
- Trial name
- PACUS (NCT02625740)
- Testing
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty, Flow occlusion with an angioplasty balloon
- Volunteers
- 56 people
- Sponsor
- University of Rome Tor Vergata
Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Atherosclerotic Ischemic Disease, Critical Limb Ischemia
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal…
- Conditions
- Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04583436
- Testing
- Endovascular recanalization, Open surgery
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Chronic Limb-Threatening Ischemia
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
- Trial name
- HEAL-SCS (NCT05322798)
- Testing
- High-frequency SCS, Low-frequency SCS
- Where
- Russia
- Volunteers
- 25 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Cryoplasty CLIMB-registry
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected.
- Trial name
- CLIMB (NCT00459888)
- Testing
- PolarCath Peripheral Dilatation System (Boston Scientific)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular
Critical Lower Limb Ischemia
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
- Trial name
- NCT04490408
- Testing
- long surgical bypass, Hybrid approach
- Volunteers
- 52 people
- Sponsor
- Egyptian Biomedical Research Network
Peripheral Artery Disease, Critical Limb Ischemia
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™)…
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication
- Trial name
- NCT02389023
- Testing
- standard gauze dressing, Prevena Incision Management system
- Where
- 5 sites in United States
- Volunteers
- 242 people
- Sponsor
- University of Vermont Medical Center
Critical Limb Ischemia Due to Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of…
- Trial name
- NCT03056742
- Testing
- Stempeucel(R)
- Where
- 8 sites in India
- Sponsor
- Stempeutics Research Pvt Ltd
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia