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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Unknown status
CT.gov ID
NCT03428204
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
22.1
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Balloon dilation during 180 seconds
  • Procedure: Balloon dilation during 300 seconds
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The effect of two balloon inflation times will be evaluated in peripheral balloon angioplastyThe effect of two balloon inflation times will be evaluated in peripheral balloon angioplasty
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial
Actual Study Start Date :
Nov 28, 2017
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 180 seconds balloon dilation

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

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

    		•
    Other: 300 seconds balloon dilation

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cliniques universitaires Saint-Luc Brussels Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    • Principal Investigator: Parla Astarci, MD, PhD, Cliniques universitaires Saint-Luc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT03428204
    Other Study ID Numbers:
    • 2017/17AOU/406
    First Posted:
    Feb 9, 2018
    Last Update Posted:
    Mar 11, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 11, 2019