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Optimal Predilatation Technique for BVS Implantation (OPTI-BVS)

Primary Purpose

Coronary Artery Stenosis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Predilatation with non-compliant balloon
Predilatation with scoring balloon (Scoroflex)
Predilatation with cutting balloon (Flextome)
Sponsored by
Cardiology Center Agel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring PCI, bioabsorbable scaffold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing percutaneous coronary intervention (PCI)
  • lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment

Exclusion Criteria:

  • patients with acurate myocardial infarction (STEMI)
  • patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Non-compliant balloon

    Scoring balloon

    Cutting balloon

    Arm Description

    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

    Outcomes

    Primary Outcome Measures

    Minimal lumen area (MLA) in the BVS (mm2)
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.

    Secondary Outcome Measures

    Clinically - driven target vessel revascularization
    Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.
    Eccentricity index
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Eccentricity index is calculated as minimal luminal diameter divided by maximal luminal diameter in the MLA segment.
    Expansion index
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Expansion index is calculated as minimal luminal diameter divided by maximal expected diameter of the non-compliant balloon used for high pressure postdilatation.

    Full Information

    First Posted
    October 21, 2016
    Last Updated
    October 25, 2016
    Sponsor
    Cardiology Center Agel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02946320
    Brief Title
    Optimal Predilatation Technique for BVS Implantation
    Acronym
    OPTI-BVS
    Official Title
    Optimal Predilatation Technique for BVS Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cardiology Center Agel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
    Detailed Description
    Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Stenosis
    Keywords
    PCI, bioabsorbable scaffold

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-compliant balloon
    Arm Type
    Active Comparator
    Arm Description
    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
    Arm Title
    Scoring balloon
    Arm Type
    Experimental
    Arm Description
    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
    Arm Title
    Cutting balloon
    Arm Type
    Experimental
    Arm Description
    15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
    Intervention Type
    Device
    Intervention Name(s)
    Predilatation with non-compliant balloon
    Intervention Description
    Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
    Intervention Type
    Device
    Intervention Name(s)
    Predilatation with scoring balloon (Scoroflex)
    Intervention Description
    Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
    Intervention Type
    Device
    Intervention Name(s)
    Predilatation with cutting balloon (Flextome)
    Intervention Description
    Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
    Primary Outcome Measure Information:
    Title
    Minimal lumen area (MLA) in the BVS (mm2)
    Description
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.
    Time Frame
    Immediately after BVS implantation
    Secondary Outcome Measure Information:
    Title
    Clinically - driven target vessel revascularization
    Description
    Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.
    Time Frame
    12 months after the procedure
    Title
    Eccentricity index
    Description
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Eccentricity index is calculated as minimal luminal diameter divided by maximal luminal diameter in the MLA segment.
    Time Frame
    Immediately after BVS implantation
    Title
    Expansion index
    Description
    After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Expansion index is calculated as minimal luminal diameter divided by maximal expected diameter of the non-compliant balloon used for high pressure postdilatation.
    Time Frame
    Immediately after BVS implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing percutaneous coronary intervention (PCI) lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment Exclusion Criteria: patients with acurate myocardial infarction (STEMI) patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Petra Jiroušková, Mgr
    Phone
    +420466014182
    Email
    petra.jirouskova@kca.agel.cz
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ivo Varvařovský, MUDr, Ph.D
    Organizational Affiliation
    Cardiology Center AGEL a.s.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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