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Frontier Registry II Bifurcation Stent System Registry

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Multi-Link Frontier Coronary Stent System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria: Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure. Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (>2.5mm and <4.0mm diameter with a side branch of >2.0mm) with a lesion length <15mm determined by visual assessment . Target main branch vessel must be a major epicardial native vessel. Appropriate lesion morphology. Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis). Exclusion Criteria: Estimated artery reference diameter <2.5mm Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel Target lesion contains thrombus. Target lesion is aorto-ostial or left main stem location. Untreated lesion >50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention. Patients with a contraindication for anti-platelet / anti-coagulation therapy. Target lesion distal to previously placed stents. Fibrotic or calcified lesions that cannot be pre-dilated.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    I

    Arm Description

    Consecutive patients, open label

    Outcomes

    Primary Outcome Measures

    Incidence of Major Adverse Cardiac Events (MACE): Death, Q-wave and non-Q wave Myocardial Infarction, Target Lesion Revascularization (main branch and side branch) including PTCA and CABG at 6 months (180 days).
    Acute ischemic, hemorrhagic and vascular complications.
    Target Vessel Failure (TVF) rate (Death, Q-wave and non-Q-wave Myocardial Infarction and Target Vessel Revascularization (TVR) including PTCA and CABG at one month (30 days) and six months (180 days) follow up.
    Acute success of stent delivery, deployment, and post dilatation.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2006
    Last Updated
    May 12, 2015
    Sponsor
    Abbott Medical Devices
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00286195
    Brief Title
    Frontier Registry II Bifurcation Stent System Registry
    Official Title
    The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was withdrawn due to a business decision.
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott Medical Devices

    4. Oversight

    5. Study Description

    Brief Summary
    To assess the procedural success, performance, 30-day and 6 month clinical outcome of bifurcation stenting, and the six month incidence of clinically indicated target lesion revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.
    Detailed Description
    The purpose of this study is to assess the performance of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System (CBSS) with one and six months clinical outcomes, when used for bifurcation de novo or restenotic lesion treatment. The device allows for a stent to be implanted in the main branch and simultaneous preservation and access of the side branch for balloon dilatation or stenting when indicated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I
    Arm Type
    No Intervention
    Arm Description
    Consecutive patients, open label
    Intervention Type
    Device
    Intervention Name(s)
    Multi-Link Frontier Coronary Stent System
    Intervention Description
    Bare metal stent
    Primary Outcome Measure Information:
    Title
    Incidence of Major Adverse Cardiac Events (MACE): Death, Q-wave and non-Q wave Myocardial Infarction, Target Lesion Revascularization (main branch and side branch) including PTCA and CABG at 6 months (180 days).
    Time Frame
    180 days and one year
    Title
    Acute ischemic, hemorrhagic and vascular complications.
    Time Frame
    one year
    Title
    Target Vessel Failure (TVF) rate (Death, Q-wave and non-Q-wave Myocardial Infarction and Target Vessel Revascularization (TVR) including PTCA and CABG at one month (30 days) and six months (180 days) follow up.
    Time Frame
    6 months
    Title
    Acute success of stent delivery, deployment, and post dilatation.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure. Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (>2.5mm and <4.0mm diameter with a side branch of >2.0mm) with a lesion length <15mm determined by visual assessment . Target main branch vessel must be a major epicardial native vessel. Appropriate lesion morphology. Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis). Exclusion Criteria: Estimated artery reference diameter <2.5mm Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel Target lesion contains thrombus. Target lesion is aorto-ostial or left main stem location. Untreated lesion >50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention. Patients with a contraindication for anti-platelet / anti-coagulation therapy. Target lesion distal to previously placed stents. Fibrotic or calcified lesions that cannot be pre-dilated.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    D Dudek, MD
    Organizational Affiliation
    Jagiellonian University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Frontier Registry II Bifurcation Stent System Registry

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