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

NCT01489761 | Terminated Phase 4 DMC

• 1 other identifier: CVRF2011-9
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

long lesions; drug eluting stents

Outcome Measures

Primary Outcomes (1)

• In-segment late luminal loss at 13 month follow-up

  13 month post stenting

Secondary Outcomes (15)

• 1. All Death

  12 month clinical follow-up

• 2. Cardiac death

  12 month clinical follow-up

• 3. Myocardial infarction (MI)

  12 month clinical follow-up

• 4. Composite of death or MI

  12 month clinical follow-up

• 5. Composite of cardiac death or MI

  12 month clinical follow-up

Study Arms (2)

zotarolimus-eluting stent

ACTIVE COMPARATOR

Resolute Integrity or Resolute Onyx stent

Device: percutaneous coronary intervention

everolimus-eluting stent

EXPERIMENTAL

Xience Prime or Xience Xpedition or Xience Alpine stent

Device: percutaneous coronary intervention

Interventions

percutaneous coronary intervention DEVICE

drug eluting stent implantation

Also known as: Resolute Integrity or Resolute Onyx stent, Xience Prime or Xience Xpedition or Xience Alpine stent

everolimus-eluting stent; zotarolimus-eluting stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seung-Jung Park: lead
• Abbott: collaborator
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (11)

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National university hospital

Daegu, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyunghee University Medical Center

Seoul, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Location

St.carollo Hospital

Suncheon, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: January 1, 2012
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11)