Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial

Critical Limb Ischemia Clinical Trial

Official title:
Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.

Clinical Trial Description

Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN). All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered. To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial. If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission Patient will be randomised to one of the following groups: A. Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04760119
Study type	Interventional
Source	Lithuanian University of Health Sciences
Contact	Viktoras Šliaužys, M.D.
Phone	+37064297161
Email	viktoras.sliauzys@lsmuni.lt
Status	Recruiting
Phase	N/A
Start date	March 1, 2020
Completion date	January 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK Artery Disease	N/A
Recruiting	`NCT03668353` - Recombinant SeV-hFGF2/dF Injection for PAOD	Phase 1
Recruiting	`NCT04110964` - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT	Phase 1
Not yet recruiting	`NCT03994666` - Cell Therapy in Critical Limb Ischemia	Phase 2
Recruiting	`NCT02389023` - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery	N/A
Completed	`NCT02539940` - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Not yet recruiting	`NCT02498080` - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia	N/A
Recruiting	`NCT02239419` - Evaluation of Carbothera in the Treatment of Foot Ulcers	N/A
Recruiting	`NCT01938872` - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia	N/A
Active, not recruiting	`NCT01211925` - Distal Venous Arterialisation of Ischemic Limb	Phase 2/Phase 3
Completed	`NCT02454231` - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)	Phase 2/Phase 3
Completed	`NCT01758874` - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia	Phase 2
Completed	`NCT02475200` - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting	`NCT04583436` - 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	N/A
Completed	`NCT04071782` - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore	N/A
Completed	`NCT03669458` - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.	N/A
Not yet recruiting	`NCT06007469` - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting	`NCT04110327` - An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed	`NCT02260622` - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia	Phase 2
Recruiting	`NCT02054416` - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.