Frontier Registry II Bifurcation Stent System Registry

Study Overview
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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.

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.

Official Title
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The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Multi-Link Frontier Coronary Stent System


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: I<br>Consecutive patients, open label | Device: Multi-Link Frontier Coronary Stent System<br>* Bare metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 180 days and one year | 
| Acute ischemic, hemorrhagic and vascular complications. |  | one year | 
| 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. |  | 6 months | 
| Acute success of stent delivery, deployment, and post dilatation. |  | 30 days |