Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial.

Summary

Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease and have negative impact upon the outcomes of the treatment.

Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of inflation of angioplasty balloon would reduce the rate of severe arterial dissections and necessity in bailout stenting during the treatment of occlusive-stenotic femoropopliteal lesions in patients with chronic limb threatening ischemia.

Methods. The LOVES trial is a single centre, two parallel groups, controlled trial with 1:1 randomization. Participants will be recruited among the patients hospitalized in Vascular Surgery Department of Institute of Emergency Medicine, Chisinau, Republic of Moldova.

Procedure. Diagnostic angiography of the treated limb will be performed first to confirm the presence of stenosis ≥50% or occlusion in the superficial femoral and/or popliteal artery. After crossing of the lesion patient will be supposed to randomization. In the intervention group the angioplasty balloon will be inflated for 6 minutes. In the control group - for 3 minutes.

Presence and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on completion angiography. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 investigators.

Sample size. Basing on the results of previous retrospective study investigators expect the 23% rate of severe dissection in study group (6 minutes inflation) and 51% - in control group (3 minutes inflation). Using the probability of type I error of 0.05 and power set at 80% investigators have calculated that 45 patients are required for each group. Anticipating 10% rate of loss to follow-up, 50 patients will be randomized per treatment arm.

Randomization. One hundred patients will be allocated to study or control group by two blocks 1:1 randomization using the free online application Research Randomizer, version 4 (Urbaniak GC, Plous S., 2013, http://www.randomizer.org/).

Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled.

Conditions

• Peripheral Arterial Disease
• Dissection Arterial

Interventions

PROCEDURE

Percutaneous transluminal angioplasty

Under local anesthesia the percutaneous arterial access will be created. Digital subtraction angiography of the whole limb will be performed. Occlusive-stenotic lesion of the superficial femoral and / or popliteal artery will be crossed with a guidewire. The plain old (non drug-eluting) will be positioned in the affected arterial segment and inflated up to nominal pressure. After balloon deflation and extraction the completion angiography will be performed. Presence (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on DSA images in 2 directions. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 from 3 investigators.

Sponsors & Collaborators

• Dumitru Casian

  lead OTHER

Principal Investigators

• Dumitru Casian, MD, PhD · Nicolae Testemitanu State University of Medicine and Pharmacy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-24

Primary Completion

2022-06-22

Completion

2023-06-23

Countries

• Moldova

Study Locations