Femoropopliteal Arterial Stenosis
Conditions
Brief summary
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.
Interventions
PROCEDUREBalloon dilation during 180 seconds
Percutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
PROCEDUREBalloon dilation during 300 seconds
Percutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The effect of two balloon inflation times will be evaluated in peripheral balloon angioplasty
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of residual stenosis between both groups | at 3 or 5 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of redilatation or additional stenting between both groups | at 3 or 5 minutes | 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. |
Countries
Belgium
Contacts
Primary ContactParla Astarci, MD, PhD
Backup ContactMaxime Elens, MD
Outcome results
None listed