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

Femoropopliteal Arterial Stenosis Clinical Trial

— Balloon-angio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428204
• Other study ID #: 2017/17AOU/406
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: March 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Parla Astarci, MD, PhD
• Phone: 0032 2 764
• Email: parla.astarci[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoropopliteal Arterial Stenosis

Intervention

Procedure:
• Balloon dilation during 180 seconds
Percutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
• Balloon dilation during 300 seconds
Percutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 3 or 5 minutes
Secondary	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.	at 3 or 5 minutes