Frontier Registry II Bifurcation Stent System Registry

Abbott

Status and phase

Withdrawn

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Multi-Link Frontier Coronary Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00286195

Frontier Registry II

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No 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.