Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry

Phase 4

• Conditions: Ischemic Heart Disease/Coronary Artery Disease

• Registration Number: JPRN-UMIN000008076
• 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: 2012-06-04
• Study Completion: 2013-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

1. Women known to be pregant or lactating mothers. 2. Known hypersensitivity or allergy to drugs including aspirin, heparin, clopidogrel, ticlopidine, and ABT- 578; rapamycin, tacrolimus, sirolimus, or their analogues, or other analogues/derivatives; or cobalt, chrome, nickel, molybdenum, or contrast media. 3. Life expectancy estimated to be less than 12 months. 4. Acute myocardial infarction (AMI) accompanied by cardiogenic shock. 5. Preexisting stents (drug-eluting stents [DES] or bare metal stents [BMS]) in the target vessel (stents in a branch of the target vessel do not preclude enrollment). 6. Patients known to have difficulty in continuing dual antiplatelet therapy (DAPT) because of a plan of other surgery after stenting.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiac events (MACE; defined as all-cause death, myocardial infarction, coronary artery bypass grafting, and target lesion revascularization [TLR]) at 12 months post-procedure.

Secondary Outcome Measures

Name	Time	Method
Incidence of subacute stent thrombosis between 0 and 30 days post-procedure, and incidence of late-onset stent thrombosis between 31 and 360 days post-procedure.