Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Abbott
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01348022
First received: April 22, 2011
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

This study is a multicenter, open label, prospective, single arm trial

Single arm group; following angiography, eligible patients with unprotected LMCA stenosis >50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial

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

Primary Outcome Measures:
  • MACCE free survival [ Time Frame: at 2 year ] [ Designated as safety issue: Yes ]
    Death (all-cause mortality) Cerebrovascular accident Non-fatal myocardial infarction (Q wave and non-Q wave) Ischemia-driven target vessel revascularization either percutaneous or surgical treatment


Secondary Outcome Measures:
  • Death(all cause and cardiac) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cerebrovascular accident [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    angiographic follow-up

  • Late luminal loss in both in-stent and in-segment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    angiographic follow-up

  • pattern of restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    angiographic follow-up

  • Angina status [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Re-hospitalization with a cardiac cause [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 401
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Xience V stent
unprotected Left Main Coronary Artery stenting treated with Xience V stent

Detailed Description:

The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES.

All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coronary artery disease requiring drug eluting stents

Criteria

Inclusion Criteria:

  1. The patient must be at least 18 years of age.
  2. Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)
  3. Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
  4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
  5. 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:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin
    • Aspirin
    • Both Clopidogrel and TIclopidine
    • Everolimus, paclitaxel, ABT 578
    • Stainless steel and/or
    • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
  2. Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
  3. Any previous PCI within 1 year
  4. Previous bypass surgery
  5. Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
  6. Intention to treat more than one totally occluded major epicardial vessel
  7. Acute MI patients within 1 week
  8. Patients with EF<30%.
  9. Patients with cardiogenic shock
  10. Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
  11. Creatinine level 2.0mg/dL or dependence on dialysis.
  12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
  13. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  14. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  15. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  16. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
  17. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  19. Subject unable or unwilling to follow-up with visits required by protocol
  20. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  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: NCT01348022

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Abbott
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01348022     History of Changes
Other Study ID Numbers: 2009-0361
Study First Received: April 22, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014