NCT02452736

Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)

CHINA RESOLUTE INTEGRITY STUDY Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use --A Prospective, Multi-center, Single Arm, Non-randomized Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Detailed description

This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study. The objective of this study is to: * To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients * To assess the in-hospital Major Adverse Cardiac Event (MACE) rate * To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study. The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge. An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.

Conditions

• Ischemic Heart Disease
• Cardiovascular Diseases
• Arteriosclerosis
• Coronary Artery Disease

Interventions

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

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2015-05-25
• Last updated: 2016-04-07

Locations

2 sites across 1 country: China