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Frontier Registry II Bifurcation Stent System Registry

This study has been withdrawn prior to enrollment.
(Study was withdrawn due to a business decision.)
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00286195
First received: February 2, 2006
Last updated: September 12, 2008
Last verified: September 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: I
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

No publications provided

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013