NCT01638507

An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity 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 4.2 mm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Detailed description

The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Resolute Integrity Stent	Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-06-01
• Completion: 2015-06-01
• First posted: 2012-07-11
• Last updated: 2019-04-03
• Results posted: 2015-11-25

Locations

1 site across 1 country: United States