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Coronary Artery DiseaseNCT01348022

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

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 21 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
397 participants
Where
21 sitesSouth Korea
Study dates
Aug 2009to Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Coronary artery disease requiring drug eluting stents

Who may be able to join

  • The patient must be at least 18 years of age.
  • Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)
  • Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
  • 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
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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).
  • Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
  • Any previous PCI within 1 year
  • Previous bypass surgery
  • Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
  • Intention to treat more than one totally occluded major epicardial vessel
  • Acute MI patients within 1 week
  • Patients with EF<30%.
  • Patients with cardiogenic shock
  • Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
  • Creatinine level 2.0mg/dL or dependence on dialysis.
  • Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  • Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
  • 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).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Subject unable or unwilling to follow-up with visits required by protocol
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

South Korea21 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

  • Kangwon National University Hospital

    Chuncheon

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Chungnam National University Hospital

    Daejeon

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

    Daejeon

  • Gangneung Asan Hospital

    Gangneung

  • Chonnam National University Hospital

    Gwangju

  • Kwangju Christian Hospital

    Kwangju

  • Asan Medical Center

    Seoul, 138-736

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University hospital

    Seoul

  • Severance Hospital

    Seoul

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul

  • Veterans Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

About this study

Official title: Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial

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

Read the 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.

Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01348022
Study groupRoleWhat they receive
Xience V stentunprotected Left Main Coronary Artery stenting treated with Xience V stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE free survival

    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

    Measured: at 2 year

Secondary outcomes (11)

  1. Death(all cause and cardiac)

    Measured: 5 years

  2. Myocardial Infarction

    Measured: 5 years

  3. Cerebrovascular accident

    Measured: 5 years

  4. Target vessel revascularization

    Measured: 5 years

  5. Target lesion revascularization

    Measured: 5 years

  6. Stent thrombosis

    Measured: 5 years

  7. Binary restenosis in both in-stent and in-segment

    angiographic follow-up

    Measured: 9 months

  8. Late luminal loss in both in-stent and in-segment

    angiographic follow-up

    Measured: 9 months

  9. pattern of restenosis

    angiographic follow-up

    Measured: 9 months

  10. Angina status

    Measured: 5 years

  11. Re-hospitalization with a cardiac cause

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2012
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01348022
Sponsor's protocol ID
2009-0361
Status last verified
Nov 2015
First submitted
22 Apr 2011
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim YH, Park DW, Ahn JM, Yun SC, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Jang Y, Jeong MH, Kim HS, Hur SH, Rha SW, Lim DS, Her SH, Seung KB, Seong IW, Park SJ; PRECOMBAT-2 Investigators. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study. JACC Cardiovasc Interv. 2012 Jul;5(7):708-17. doi: 10.1016/j.jcin.2012.05.002.

    PubMed 22814775

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 21 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE free survival (time frame: at 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01348022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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