LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Seung-Jung Park

Status and phase

Terminated

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01489761

CVRF2011-9

Details and patient eligibility

About

This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.

Full description

Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

Enrollment

302 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age more than 20 years
Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)
The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion criteria

Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, zotarolimus, or everolimus
An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
Acute ST-segment-elevation MI or cardiogenic shock
Terminal illness with life expectancy < 1 year
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted
Patients with EF < 30%
Serum creatinine level >=2.0mg/dL or dependence on dialysis
Patients with left main stem stenosis (> 50% visual estimate)