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

Associations for Establishment of Evidence in Interventions1 site in 1 country1,204 target enrollmentMarch 2013

ConditionsCoronary Artery Disease Drug-eluting Stent

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Associations for Establishment of Evidence in Interventions
Enrollment: 1204
Locations: 1
Primary Endpoint: TLF (target lesion failure)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

April 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Associations for Establishment of Evidence in Interventions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 20 years or older.
•Patients with symptomatic coronary disease.
•Patients with a clinical indication for PCI and stenting of at least one coronary lesion, visually confirmed on coronary angiography.
•Patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index PCI.
•Patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study.
•Patients in whom more than 50% occlusion or stenosis is visually confirmed in a native coronary artery with a diameter of 2.5 mm - 3.5 mm on coronary angiography and that has an anatomical structure suitable for PCI using Resolute Integrity zotarolimus-eluting stent.

Exclusion Criteria

•Patients aged 85 years or older.
•Patients with cardiogenic shock.
•Patients who are pregnant or possibly pregnant.
•Patients who cannot comply with the antiplatelet therapy specified for this clinical study.
•Patients scheduled to undergo elective surgery within 6 months post-index PCI.
•Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives.
•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.
•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.
•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.

Outcomes

Primary Outcomes

TLF (target lesion failure)

Time Frame: 12 months

The composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel) or Target Lesion Revascularization (TLR; clinically indicated) (= device oriented endpoint).

Secondary Outcomes

Duration of dual antiplatelet therapy(12, 24 and 36 months after index PCI)
TLF (target lesion failure)(30 days, 6, 9, 12, 24 and 36 months after index PCI)
Stent thrombosis(30 days, 6, 9, 12, 24 and 36 months after index PCI)
Delivery success(stent implantation until hospital discharge (average 1-5 days))
Lesion success(stent implantation until hospital discharge (average 1-5 days))
TVF (target vessel failure)(30 days, 6, 9, 12, 24 and 36 months after index PCI)
MACE (major adverse cardiac event)(30 days, 6, 9, 12, 24 and 36 months after index PCI)
Procedure success(stent implantation until hospital discharge (average 1-5 days))
Cerebrovascular accident(30 days, 6, 9, 12, 24 and 36 months afetr index PCI)