NCT00726453

The Medtronic RESOLUTE US Clinical Trial

A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,516 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Resolute Zotarolimus-Eluting Coronary Stent	Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-01-01
• Completion: 2016-03-01
• First posted: 2008-08-01
• Last updated: 2016-05-23
• Results posted: 2012-05-25

Locations

1 site across 1 country: United States