Frontier Registry II Bifurcation Stent System Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00286195
• Other study ID #: Frontier Registry II
• Status: Withdrawn
• Phase: Phase 4
• First received: February 2, 2006
• Last updated: May 12, 2015
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Multi-Link Frontier Coronary Stent System
Bare metal stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Acute ischemic, hemorrhagic and vascular complications.		one year	Yes
Primary	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	Yes
Primary	Acute success of stent delivery, deployment, and post dilatation.		30 days	Yes