Clinical trial NCT00485004: Focal In-stent Restenosis After Drug-Eluting Stent
Official title: FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: In Stent Restenosis
Keywords: Coronary artery disease
Stent
Angioplasty
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2007-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Binary In-segment Restenosis
timeFrame: At 9 months angiographic follow-up
Secondary outcomes:
measure: Composite end-point of death, myocardial infarction, or target vessel revascularization
timeFrame: At 9-month after index procedure
measure: Stent thrombosis
timeFrame: In-hospital, 30 days, 9 months, and 1year
measure: Late luminal loss
timeFrame: at 8 month angiographic follow-up
measure: 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
timeFrame: during the hospital stay
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Choeng Ju
country: Korea, Republic of
facility: Choeng Ju St.Mary's Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: GangNeung
country: Korea, Republic of
facility: Asan Medical Center
city: Gyongju
country: Korea, Republic of
facility: DongGuk University Gyongju Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: PyeongChon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital,
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyungsang University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: