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This study has been withdrawn prior to enrollment.
(Study was withdrawn due to a business decision.)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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014