Focal In-stent Restenosis After Drug-Eluting Stent

Phase 4

Completed

• Conditions: In Stent Restenosis
• Interventions: Device: Cutting balloon; Device: Sirolimus-eluting stent

• Registration Number: NCT00485004
• Lead Sponsor: Seung-Jung Park

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cutting balloon	Sirolimus-eluting stent	Cutting balloon
Cutting balloon	Cutting balloon	Cutting balloon
Sirolimus-eluting stent	Cutting balloon	Sirolimus-eluting stent
Sirolimus-eluting stent	Sirolimus-eluting stent	Sirolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
Binary In-segment Restenosis	At 9 months angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
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
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
Late luminal loss	at 8 month angiographic follow-up

Trial Locations

Locations (14)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Kwangju Christian Hospital; 🇰🇷 Kwangju, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

DongGuk University Gyongju Hospital; 🇰🇷 Gyongju, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Seoul Veterans Hospital; 🇰🇷 Seoul, Korea, Republic of

Choeng Ju St.Mary's Hospital; 🇰🇷 Choeng Ju, Korea, Republic of

Hallym University Sacred Heart Hospital,; 🇰🇷 PyeongChon, Korea, Republic of

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyungsang University Hospital; 🇰🇷 Seoul, Korea, Republic of