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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485004

Locations
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
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Kyungsang University Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00485004     History of Changes
Other Study ID Numbers: 20070041
Study First Received: June 11, 2007
Last Updated: August 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014