Frontier Registry II Bifurcation Stent System Registry

NCT00286195 | Withdrawn Phase 4

• 1 other identifier: Frontier Registry II
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• 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

• Acute ischemic, hemorrhagic and vascular complications.

  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.

  6 months

• Acute success of stent delivery, deployment, and post dilatation.

  30 days

Study Arms (1)

I

NO INTERVENTION

Consecutive patients, open label

Device: Multi-Link Frontier Coronary Stent System

Interventions

Multi-Link Frontier Coronary Stent System DEVICE

Bare metal stent

I

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• D Dudek, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 3, 2006
• Study Start: December 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 13, 2015

Record last verified: 2015-05