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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008076

Enrollment

1000

Registered

2012-06-04

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease/Coronary Artery Disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or older. 2. Clinical symptoms of ischemic heart disease, OR ischemia confirmed by cardiac function tests. 3. Patients eligible for percutaneous transluminal coronary angioplasty (PTCA) and stent implant procedure. 4. Pre-procedure consent to the details and conditions of the study after pre- procedure explanation of the study, in principle. Post-procedure patient enrollment requires prior approval of the joint ethical committee for the method of post-procedure enrollment.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactSatoru Otsuji

Higashi Takarazuka Satoh Hospital Department of Cardiology

aeei_trial@aeeijapan.org+81.797.88.2200

Outcome results