Frontier Registry II Bifurcation Stent System Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Consecutive patients, open label

Group Type NO_INTERVENTION

Multi-Link Frontier Coronary Stent System

Intervention Type DEVICE

Bare metal stent

Interventions

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Multi-Link Frontier Coronary Stent System

Bare metal stent

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No