Clinical trial NCT00286195: Frontier Registry II Bifurcation Stent System Registry
Official title: The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-02-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 180 days and one year
measure: Acute ischemic, hemorrhagic and vascular complications.
timeFrame: one year
measure: 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.
timeFrame: 6 months
measure: Acute success of stent delivery, deployment, and post dilatation.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jagiellonian University
name: D Dudek, MD
role: PRINCIPAL_INVESTIGATOR
References: