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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01489761
First received: December 8, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (Xience Prime or Xience Xpedition stent)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • In-segment late luminal loss at 13 month follow-up [ Time Frame: 13 month post stenting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. All Death [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 2. Cardiac death [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 3. Myocardial infarction (MI) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 4. Composite of death or MI [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 5. Composite of cardiac death or MI [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 6. Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: No ]
  • 7. Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: No ]
  • 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 9. Stent thrombosis (ARC criteria) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
  • 10. In-stent late loss [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 11. In-stent and in-segment restenosis [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 12. Angiographic pattern of restenosis [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 13. Volume of intimal hyperplasia [ Time Frame: 13 month IVUS follow-up ] [ Designated as safety issue: No ]
    sub-study

  • 14. Incidence of late stent malapposition [ Time Frame: 13 month IVUS follow-up ] [ Designated as safety issue: No ]
    sub-study

  • 15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay [ Time Frame: 2-3 days post stenting ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zotarolimus-eluting stent (RESOLUTE INTEGRITY stent) Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (Xience Prime or Xience Xpedition stent)
drug eluting stent implantation
Experimental: everolimus-eluting stent (Xience Prime or Xience Xpedition) Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (Xience Prime or Xience Xpedition stent)
drug eluting stent implantation

Detailed 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 stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition stent) by the stratified randomization method.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489761

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
8 Locations Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
Abbott
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01489761     History of Changes
Other Study ID Numbers: CVRF2011-9
Study First Received: December 8, 2011
Last Updated: February 3, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:
long lesions
drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014