Frontier Registry II Bifurcation Stent System Registry - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00286195

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Multi-Link Frontier Coronary Stent System	Phase IV

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

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). [ Time Frame: 180 days and one year ] [ Designated as safety issue: Yes ]
Acute ischemic, hemorrhagic and vascular complications. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Acute success of stent delivery, deployment, and post dilatation. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: No Intervention Consecutive patients, open label	Device: Multi-Link Frontier Coronary Stent System Bare metal stent

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286195

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:

D Dudek, MD

Jagiellonian University

More Information

Responsible Party:	Abbott Vascular ( Matt Kiely, Manager, Medical Information )
Study ID Numbers:	Frontier Registry II
Study First Received:	February 2, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00286195
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009