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

NCT04442802 | Completed

• 1 other identifier: LOVES_RCT_2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Severe post-angioplasty dissection in femoropopliteal arterial segment

  Post-angioplasty dissection of grades C-F according to NHLBI (National Heart, Lung and Blood Institute) classification, determined by the agreement between at least 2 from 3 study investigators basing on completion DSA results

  5 minutes after deflation of angioplasty balloon

Secondary Outcomes (4)

• Technical success of the procedure

  10 minutes after completion of balloon angioplasty +/- stenting

• Change in Ankle-Brahial Index

  24 hours after intervention

• Primary patency

  During the follow-up visits (1, 6, 12 months)

• Limb loss

  During the follow-up visits (1, 6, 12 months)

Study Arms (2)

Long time balloon inflation

EXPERIMENTAL

During the endovascular intervention the angioplasty balloon will be inflated for 6 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion

Procedure: Percutaneous transluminal angioplasty

Short time balloon inflation

ACTIVE COMPARATOR

During the endovascular intervention the angioplasty balloon will be inflated for 3 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion

Procedure: Percutaneous transluminal angioplasty

Interventions

Percutaneous transluminal angioplasty PROCEDURE

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.

Also known as: Plain old balloon angioplasty

Long time balloon inflation; Short time balloon inflation

Eligibility Criteria

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

You may qualify if:

• Chronic limb threatening ischemia category 4-6 according to Rutherford classification;
• Ankle-brachial index \<0.8 or \>1.4
• Clinical stage ≥2 of WIfI (Wound, Ischemia, foot Infection) classification;
• Stenosis of ≥50% or occlusion in superficial femoral or popliteal artery, confirmed by duplex ultrasound, computer tomography angiography or digital subtraction angiography;
• Use of endovascular approach for treatment of the lesion;
• Patient willing to sign informed consent.

You may not qualify if:

• Acute arterial occlusion (symptoms duration less than 14 days);
• Recurrent stenosis or occlusion of femoropopliteal segment;
• Impossibility to cross the lesion intraluminally during the endovascular intervention;
• Life expectancy of less than 1 year -

Sponsors & Collaborators

• Dumitru Casian: lead

Study Sites (1)

Nicolae Testemitanu State University of Medicine and Pharmacy, Department of surgery nr.3, Vascular Surgery Clinic

Chisinau, 2001, Moldova

Location

Related Publications (3)

• Zorger N, Manke C, Lenhart M, Finkenzeller T, Djavidani B, Feuerbach S, Link J. Peripheral arterial balloon angioplasty: effect of short versus long balloon inflation times on the morphologic results. J Vasc Interv Radiol. 2002 Apr;13(4):355-9. doi: 10.1016/s1051-0443(07)61736-9.

  PMID: 11932365 BACKGROUND

• Forauer AR, Hoffer EK, Homa K. Dialysis access venous stenoses: treatment with balloon angioplasty--1- versus 3-minute inflation times. Radiology. 2008 Oct;249(1):375-81. doi: 10.1148/radiol.2491071845.

  PMID: 18796688 BACKGROUND

• Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11.

  PMID: 30203701 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Aortic Dissection

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Dumitru Casian, MD, PhD

  Nicolae Testemitanu State University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Department of General surgery nr.3, Head of Vascular Surgery Clinic

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 23, 2020
• Study Start: August 24, 2020
• Primary Completion: June 22, 2022
• Study Completion: June 23, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)