Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment

Cliniques universitaires Saint-Luc- Université Catholique de Louvain200 enrolled

Overview

Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Femoropopliteal Arterial Stenosis

Interventions

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with symptomatic atherosclerotic stenotic lesions of the femoropopliteal artery suitable for angioplasty in the adult population Exclusion Criteria: * Artery lesions shorter than 1 cm and longer than 10 cm length, total occlusions, severe calcification, previous angioplasty with current restenosis, previous stenting with current insistent restenosis and subintimal recanalization of the lesion * No pregnant and nursing women will be included.

Outcomes

Primary Outcomes

Number of residual stenosis between both groups

The primary outcome of the study is to assess the difference in number of residual stenosis after balloon dilatation of the arterial lesion between both groups (3min and 5min). A residual stenosis (measured on the angiogram) responsible for an arterial stenosis of \>30% will be defined as unsuccessful treatment. The group with the lowest number of arterial restenosis \>30% after dilatation has the best primary outcome.

Time frame: at 3 or 5 minutes

Secondary Outcomes

Number of redilatation or additional stenting between both groups

The secondary outcome of the study is to evaluate the difference in need of redilatation or provisional stenting after the first dilatation between both groups (3 vs 5min). If an arterial stenosis of \>30% after dilatation is measured, a redilatation of an additional stenting will be placed. The group with the lowest number of redilatation or additional stenting after dilatation has the best secondary outcome.

Time frame: at 3 or 5 minutes

Central Contacts

Parla Astarci, MD, PhD

CONTACT

0032 2 764 parla.astarci@uclouvain.be

Maxime Elens, MD