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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Resolute Integrity Stent

• Registration Number: NCT01638507
• Lead Sponsor: Medtronic Vascular

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2014-06
• Study Completion: 2015-06
• Results First Submitted: 2015-10-23
• Results First Submitted QC: 2015-10-23
• Results First Posted: 2015-11-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resolute Integrity	Resolute Integrity Stent	Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)

Primary Outcome Measures

Name	Time	Method
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)	12 months

Secondary Outcome Measures

Name	Time	Method
Clinical Endpoint: TLR	12 months
Clinical Endpoint: TVR	12 months
Clinical Endpoint: ST	12 months
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI	12 months
Clinical Endpoint: Death	12 months
Dual Antiplatelet Therapy (DAPT) Compliance	12 months
Clinical Endpoint: Stroke	12 months
Clinical Endpoint: MI	12 months
Clinical Endpoint: Bleeding Complications in General	12 months

Trial Locations

Locations (1)

St. Joseph's Hospital Health Center; 🇺🇸 Syracuse, New York, United States