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

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ClinicalTrials.gov Identifier: NCT03428204
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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
Femoropopliteal Arterial Stenosis Procedure: Balloon dilation during 180 seconds Procedure: Balloon dilation during 300 seconds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : November 28, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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 Name: Balloon dilation of femoropopliteal artery lesions during 180 seconds

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 Name: Balloon dilation of femoropopliteal artery lesions during 300 seconds




Primary Outcome Measures :
  1. Number of residual stenosis between both groups [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428204


Contacts
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Contact: Parla Astarci, MD, PhD 0032 2 764 ext 6107 parla.astarci@uclouvain.be
Contact: Maxime Elens, MD 0032 2 764 ext 8063 maxime.elens@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Parla Astarci, MD, PhD    0032 2 764 ext 6107    parla.astarci@uclouvain.be   
Contact: Maxime Elens, MD    0032 2 764 ext 8063    maxime.elens@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Parla Astarci, MD, PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03428204     History of Changes
Other Study ID Numbers: 2017/17AOU/406
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No