Bare Metal Bifurcation Stent Clinical Trial in Humans

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Myocardial Ischemia
• Interventions: Device: Medtronic Bifurcation Stent System

• Registration Number: NCT00607321
• Lead Sponsor: Medtronic Vascular

Brief Summary

To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of 3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-22
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-08-01
• Results First Submitted QC: 2011-08-01
• Results First Posted: 2011-08-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Medtronic Bifurcation Stent System	Medtronic Bifurcation Stent System

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.	30 days	TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.

Secondary Outcome Measures

Name	Time	Method
Device Success	During index procedure	Device success is reported as Historical-standard definition: attainment of \<50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.
Number of Participants With Target Vessel Failure (TVF) at 6 Months	6 month	TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Number of Participants With Target Vessel Failure at 9 Months.	9 month	TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Number of Participant With Target Vessel Failure at 12 Months	12 month	TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.

Trial Locations

Locations (1)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand