Study 19 of 1004 for search of: Korea, Republic of
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Focal In-Stent Restenosis After Drug-Eluting Stent (FOCUS)
This study is currently recruiting participants.
Verified by CardioVascular Research Foundation, Korea, June 2007
Sponsored by: CardioVascular Research Foundation, Korea
Information provided by: CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00485004
  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: Sirolimus-eluting stent (cypher, J&J, Cordis)
Device: Cutting balloon
Phase IV

MedlinePlus related topics: Angioplasty
Drug Information available for: Sirolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: FOcal Type In-Stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

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 ]

Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: June 2009
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

Contacts
Contact: Seung-Jung Park, MD, PhD 02-3010-4812 ext 82 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 02-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD            
Principal Investigator: Sang-Sig Cheong, MD, PhD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD, PhD     (82-2)-3010-4812     sjpark@amc.seoul.kr    
Contact: Duk-Woo Park, MD, PhD     (82-2)-3010-3995     dwpark@amc.seoul.kr    
Principal Investigator: Seung-Jung Park, MD, PhD            
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Ki Ko, MD, PhD            
Principal Investigator: Jae-Ki Ko, MD, PhD            
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD            
Principal Investigator: In-Whan Seong, MD, PhD            
Hallym University Sacred Heart Hospital, Recruiting
PyeongChon, Korea, Republic of
Contact: Young-Jin Choi, MD, PhD            
Principal Investigator: Young-Jin Choi, MD, PhD            
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD, PhD            
Principal Investigator: Nae-Hee Lee, MD, PhD            
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD            
Principal Investigator: Sang-Gon Lee, MD, PhD            
Kwangju Christian Hospital Recruiting
Kwangju, Korea, Republic of
Contact: Seung-Wook Lee, MD, PhD            
Principal Investigator: Seung-Wook Lee, MD, PhD            
Inje University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: DongSoo Kim, MD, PhD            
Principal Investigator: Dong Soo Kim, MD, PhD            
Kyungsang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chung-Whan Kwak, MD, PhD            
Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Wo Jung Park, MD, PhD            
Principal Investigator: Woo Jung Park, MD, PhD            
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of
Contact: Keun Lee, MD, PhD            
Principal Investigator: Keun Lee, MD, PhD            
Choeng Ju St.Mary’s Hospital Recruiting
Choeng Ju, Korea, Republic of
Contact: Yong-Mo Yang, MD, PhD            
Principal Investigator: Yong-Mo Yang, MD, PhD            
DongGuk University Gyongju Hospital Recruiting
Gyongju, Korea, Republic of
Contact: Deuk Young Nah, MD, PhD            
Principal Investigator: Deuk Young Nah, MD, PhD            
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Byoung Ryul Cho, MD, PhD            
Principal Investigator: Byung Ryul Cho, MD, PhD            
Sponsors and Collaborators
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

Study ID Numbers: 20070041
Study First Received: June 11, 2007
Last Updated: June 11, 2007
ClinicalTrials.gov Identifier: NCT00485004  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Study placed in the following topic categories:
Sirolimus
Coronary Disease
Clotrimazole
Miconazole
Tioconazole
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on January 16, 2009