Coronary Artery Disease
Conditions
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.
Interventions
DEVICEMulti-Link Frontier Coronary Stent System
Bare metal stent
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed