Frontier Registry II Bifurcation Stent System Registry

May 12, 2015 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: I
Consecutive patients, open label
Device: Multi-Link Frontier Coronary Stent System
Bare metal stent

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: 180 days and one year
180 days and one year
Acute ischemic, hemorrhagic and vascular complications.
Time Frame: one year
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.
Time Frame: 6 months
6 months
Acute success of stent delivery, deployment, and post dilatation.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: D Dudek, MD, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frontier Registry II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe