Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment (Balloon-angio)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Femoropopliteal Arterial Stenosis

Treatments: Procedure: Balloon dilation during 300 seconds; Procedure: Balloon dilation during 180 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT03428204

2017/17AOU/406

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

180 seconds balloon dilation

Other group

Description:

Percutaneous angioplasty with balloon dilation during 180 seconds for percutaneous treatment of femoropopliteal artery stenosis

Treatment:

Procedure: Balloon dilation during 180 seconds

300 seconds balloon dilation

Other group

Description:

Percutaneous angioplasty with balloon dilation during 300 seconds for percutaneous treatment of femoropopliteal artery stenosis

Treatment:

Procedure: Balloon dilation during 300 seconds