NCT03428204

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

Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoropopliteal Arterial Stenosis

Interventions

Type	Name	Description
PROCEDURE	Balloon dilation during 180 seconds	Percutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
PROCEDURE	Balloon dilation during 300 seconds	Percutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2018-02-09
• Last updated: 2019-03-11

Locations

1 site across 1 country: Belgium