The Medtronic RESOLUTE US Clinical Trial

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Resolute Zotarolimus-Eluting Coronary Stent

• Registration Number: NCT00726453
• Lead Sponsor: Medtronic Vascular

Brief Summary

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.

Detailed Description

The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Primary Completion: 2011-01
• Results First Submitted: 2012-01-31
• Results First Submitted QC: 2012-05-23
• Results First Posted: 2012-05-25
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1516

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resolute Zotarolimus-Eluting Coronary Stent	Resolute Zotarolimus-Eluting Coronary Stent	Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 Months	Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event (MACE)	12 months	Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
Target Vessel Failure (TVF)	12 months	Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
Death	12 months
Stent Thrombosis (ST)	12 months	Stent Thrombosis (ST) (as determined by historic and ARC definitions).
Target Vessel MI	12 months	Target Vessel MI (as determined by extended historical and ARC definitions).

Trial Locations

Locations (1)

East Texas Medical Center; 🇺🇸 Tyler, Texas, United States