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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 24, 2020

Primary Completion Date

June 22, 2022

Study Completion Date

June 23, 2023

Conditions
Peripheral Arterial DiseaseDissection 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.

Trial Locations (1)

2001

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

All Listed Sponsors
lead

Dumitru Casian

OTHER

NCT04442802 - Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial. | Biotech Hunter | Biotech Hunter