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Focal In-stent Restenosis After Drug-Eluting Stent (FOCUS)

This study has been completed.
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea Identifier:
First received: June 11, 2007
Last updated: August 6, 2012
Last verified: August 2012
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty

Condition Intervention Phase
In Stent Restenosis
Device: Cutting balloon
Device: Sirolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Binary In-segment Restenosis [ Time Frame: At 9 months angiographic follow-up ]

Secondary Outcome Measures:
  • Composite end-point of death, myocardial infarction, or target vessel revascularization [ Time Frame: At 9-month after index procedure ]
  • Stent thrombosis [ Time Frame: In-hospital, 30 days, 9 months, and 1year ]
  • Late luminal loss [ Time Frame: at 8 month angiographic follow-up ]
  • 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 [ Time Frame: during the hospital stay ]

Enrollment: 100
Study Start Date: March 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cutting balloon
Cutting balloon
Device: Cutting balloon
Cutting balloon
Device: Sirolimus-eluting stent
Sirolimus-eluting stent
Active Comparator: Sirolimus-eluting stent
Sirolimus-eluting stent
Device: Cutting balloon
Cutting balloon
Device: Sirolimus-eluting stent
Sirolimus-eluting stent

Detailed Description:
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient must be at least 18 years of age.
  2. Restenosis after drug-eluting stents (>50% by visual estimate)
  3. Lesion length < 10 mm (focal ISR)
  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, amenable to stent-assisted percutaneous coronary intervention
  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
    • Sirolimus eluting stent
    • 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) Sirolimus use within 12 months.
  3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  6. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  7. 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).
  8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  9. Patients with EF<30%.
  10. Acute MI patients within symptom onset < 12 hours needing primary angioplasty
  11. Creatinine level 3.0mg/dL or dependence on dialysis.
  12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
  13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
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Please refer to this study by its identifier: NCT00485004

Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Choeng Ju St.Mary's Hospital
Choeng Ju, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
DongGuk University Gyongju Hospital
Gyongju, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Hallym University Sacred Heart Hospital,
PyeongChon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Kyungsang University Hospital
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT00485004     History of Changes
Other Study ID Numbers: 20070041
Study First Received: June 11, 2007
Last Updated: August 6, 2012

Keywords provided by CardioVascular Research Foundation, Korea:
Coronary artery disease

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017