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

NCT04760119 | Unknown

• 1 other identifier: VS3005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Primary, primary-assisted and secondary patency

  Clinical and ultrasound assesment

  24 months

Secondary Outcomes (13)

• Ischemic symptoms

  24 months

• Ankle-brachial index (ABI)

  24 months

• Toe-brachial index (TBI)

  24 months

• Transcutaneous oxygen tension (TcPO2)

  24 months

• Healing of tissue loss (ulcers, gangrene)

  24 months

Study Arms (2)

Vein bypass surgery first strategy

ACTIVE COMPARATOR

Procedure: Vein bypass surgery first strategy

Endovascular treatment first (drug coated balloon angioplasty) strategy

ACTIVE COMPARATOR

Procedure: Endovascular treatment first (drug coated balloon angioplasty) strategy

Interventions

Vein bypass surgery first strategy PROCEDURE

Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed.

Vein bypass surgery first strategy

Endovascular treatment first (drug coated balloon angioplasty) strategy PROCEDURE

Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.

Endovascular treatment first (drug coated balloon angioplasty) strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with type 2 diabetes mellitus
• Severe limb ischemia (Rutherford class \>=4) due to infrapopliteal, +/- popliteal disease \[ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; \>40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.\]

You may not qualify if:

• Requires primary limb amputation
• Acute limb ischemia
• Anticipated life expectancy of \<2 years
• Unsuitable for either revascularisation strategy
• Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT, 50161, Lithuania

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Viktoras Šliaužys, M.D.

CONTACT

+37064297161; viktoras.sliauzys@lsmuni.lt

Džilda Veličkienė, Prof

CONTACT

dzilda.velickiene@lsmuni.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible due to the completely different natures of the treatments allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: The treatment will consist of two treatment modalities: 1) Vein bypass surgery first strategy; 2) Endovascular treatment first (drug coated balloon angioplasty) strategy

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)