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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485004
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : August 8, 2012
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty

Condition or disease Intervention/treatment Phase
In Stent Restenosis Device: Cutting balloon Device: Sirolimus-eluting stent Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Composite end-point of death, myocardial infarction, or target vessel revascularization [ Time Frame: At 9-month after index procedure ]
  2. Stent thrombosis [ Time Frame: In-hospital, 30 days, 9 months, and 1year ]
  3. Late luminal loss [ Time Frame: at 8 month angiographic follow-up ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Seung-Jung Park, 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