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

This study has been completed.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00485004
First received: June 11, 2007
Last updated: August 6, 2012
Last verified: August 2012

June 11, 2007
August 6, 2012
March 2007
March 2011   (final data collection date for primary outcome measure)
Binary In-segment Restenosis [ Time Frame: At 9 months angiographic follow-up ] [ Designated as safety issue: No ]
Binary In-segment Restenosis [ Time Frame: At 9 months angiographic follow-up ]
Complete list of historical versions of study NCT00485004 on ClinicalTrials.gov Archive Site
  • Composite end-point of death, myocardial infarction, or target vessel revascularization [ Time Frame: At 9-month after index procedure ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: In-hospital, 30 days, 9 months, and 1year ] [ Designated as safety issue: Yes ]
  • Late luminal loss [ Time Frame: at 8 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Focal In-stent Restenosis After Drug-Eluting Stent
FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
In Stent Restenosis
  • Device: Cutting balloon
    Cutting balloon
  • Device: Sirolimus-eluting stent
    Sirolimus-eluting stent
  • Experimental: Cutting balloon
    Cutting balloon
    Interventions:
    • Device: Cutting balloon
    • Device: Sirolimus-eluting stent
  • Active Comparator: Sirolimus-eluting stent
    Sirolimus-eluting stent
    Interventions:
    • Device: Cutting balloon
    • Device: Sirolimus-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00485004
20070041
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
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
CardioVascular Research Foundation, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP