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

Phase 4

• Conditions: Coronary Artery Disease

• Registration Number: JPRN-UMIN000010164
• Lead Sponsor: Associations for Establishment of Evidence in Interventions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-20
• Study Completion: 2016-02-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients aged 85 years or older. 2.Patients with cardiogenic shock. 3.Patients who are pregnant or possibly pregnant. 4.Patients who cannot comply with the antiplatelet therapy specified for this clinical study. 5.Patients scheduled to undergo elective surgery within 6 months post-index PCI. 6.Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives. 7.Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given. 8.Patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., BioLinx) contained in the materials of the study device or in whom these substances are specifically contraindicated. 9.Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.

Study & Design

• Study Type: Interventional,observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety and efficacy of Resolute Integrity stent system by assessing noninferiority of the primary endpoint against the Xience V arm from the RESOLUTE All-Comers clinical study.