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Frontier Registry II Bifurcation Stent System Registry

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ClinicalTrials.gov Identifier: NCT00286195
Recruitment Status : Withdrawn (Study was withdrawn due to a business decision.)
First Posted : February 3, 2006
Last Update Posted : May 13, 2015
Sponsor:
Information provided by:
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Multi-Link Frontier Coronary Stent System Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II
Study Start Date : December 2004
Actual Primary Completion Date : December 2006
Study Completion Date : December 2006
Arms and Interventions
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Arm Intervention/treatment
No Intervention: I
Consecutive patients, open label
 Device: Multi-Link Frontier Coronary Stent System
Bare metal stent


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Acute ischemic, hemorrhagic and vascular complications. [ Time Frame: one year ]
  3. 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 ]
  4. Acute success of stent delivery, deployment, and post dilatation. [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT00286195


Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: D Dudek, MD Jagiellonian University
More Information
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Responsible Party: Matt Kiely, Manager, Medical Information, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00286195    
Other Study ID Numbers: Frontier Registry II
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases