NCT01808391

A Prospective Multicenter Post Approval Study to Evaluate the Long-term Safety and Efficacy of the Resolute Integrity in the Japanese All-comers Patients With Coronary Artery Disease (PROPEL)

A Prospective Multicenter Post Approval Study to Evaluate the Long-term Safety and Efficacy of the Resolute Integrity in the Japanese All-comers Patients With Coronary Artery Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,204 (actual)
• Sponsor: Associations for Establishment of Evidence in Interventions · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter, historical controlled study. The present clinical study will measure non-inferiority of 12 month TLF rate compared to historical control.The selected historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is a prospective, multicenter, randomized, two-arm, international, open-label study.The historical control did not have angiographic follow up before 12 months, in the present clinical study, only subjects with clinical follow-up conducted at 12 months without any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up cohort) will be included in this analysis cohort.

Conditions

• Coronary Artery Disease
• Drug-eluting Stent

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-05-01
• Completion: 2016-04-01
• First posted: 2013-03-11
• Last updated: 2017-01-27

Locations

1 site across 1 country: Japan