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

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

Study Overview

• Status: Completed
• Conditions: In Stent Restenosis
• Intervention / Treatment: Device: Cutting balloon; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Choeng Ju, Korea, Republic of
    • Choeng Ju St.Mary's Hospital
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • GangNeung, Korea, Republic of
    • Asan Medical Center
  • Gyongju, Korea, Republic of
    • DongGuk University Gyongju Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • PyeongChon, Korea, Republic of
    • Hallym University Sacred Heart Hospital,
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Hangang Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Seoul Veterans Hospital
  • Seoul, Korea, Republic of
    • Kyungsang University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cutting balloon	Device: Cutting balloon; Cutting balloon; Device: Sirolimus-eluting stent; Sirolimus-eluting stent
Active Comparator: Sirolimus-eluting stent	Device: Cutting balloon; Cutting balloon; Device: Sirolimus-eluting stent; Sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binary In-segment Restenosis	At 9 months angiographic follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: June 11, 2007
• First Submitted That Met QC Criteria: June 11, 2007
• First Posted (Estimate): June 12, 2007

Study Record Updates

• Last Update Posted (Estimate): August 8, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Coronary artery disease; Stent; Angioplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 20070041