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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-02-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zotarolimus-eluting stent

Resolute Integrity or Resolute Onyx stent

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type DEVICE

drug eluting stent implantation

everolimus-eluting stent

Xience Prime or Xience Xpedition or Xience Alpine stent

Group Type EXPERIMENTAL

percutaneous coronary intervention

Intervention Type DEVICE

drug eluting stent implantation

Interventions

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percutaneous coronary intervention

drug eluting stent implantation

Intervention Type DEVICE

Other Intervention Names

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Resolute Integrity or Resolute Onyx stent Xience Prime or Xience Xpedition or Xience Alpine stent

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No