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Trial record 26 of 88 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

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

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE November 28, 2017
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03428204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment
Official Title  ICMJE Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Femoropopliteal Arterial Stenosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 180 seconds balloon dilation
    Percutaneous angioplasty with balloon dilation during 180 seconds for percutaneous treatment of femoropopliteal artery stenosis
    Intervention: Procedure: Balloon dilation during 180 seconds
  • 300 seconds balloon dilation
    Percutaneous angioplasty with balloon dilation during 300 seconds for percutaneous treatment of femoropopliteal artery stenosis
    Intervention: Procedure: Balloon dilation during 300 seconds
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03428204
Other Study ID Numbers  ICMJE 2017/17AOU/406
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Parla Astarci, MD, PhD Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP