Diffuse Type In-Stent Restenosis After Drug-Eluting Stent

NCT ID: NCT00485030

Last Updated: 2012-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-10-31

Brief Summary

To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.

Detailed Description

Despite a significant reduction of angiographic restenosis and the need for repeat revascularization after introduction of DES, post-DES restenosis still occur and the treatment for DES failure is challenging. However, there have been little data for therapeutic strategy for post-DES restenosis, especially diffuse type ISR. Therefore, we need the well-designed randomized trial to achieve the best therapeutic option for the treatment of diffuse type post-DES restenosis.

Conditions

In-stent Restenosis

Keywords

coronary artery disease; stent; angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cypher

sirolimus-eluting stent

Group Type: EXPERIMENTAL

Cypher

Intervention Type: DEVICE

sirolimus-eluting stent

Xience-V

Intervention Type: DEVICE

everolimus-eluting stent

Xience-V

everolimus-eluting stent

Group Type: ACTIVE_COMPARATOR

Cypher

Intervention Type: DEVICE

sirolimus-eluting stent

Xience-V

Intervention Type: DEVICE

everolimus-eluting stent

Interventions

Cypher

sirolimus-eluting stent

Intervention Type: DEVICE

Xience-V

everolimus-eluting stent

Intervention Type: DEVICE

Other Intervention Names

sirolimus-eluting stent; everolimus-eluting stent

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 (diffuse type 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Choeng Ju St.Mary's Hospital

Choeng Ju, , South Korea

Kangwon National University Hospital

Chuncheon, , South Korea

Asan Medical Center

Gangneung, , South Korea

DongGuk University Gyongju Hospital

Gyongju, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Kwangju Christian Hospital

Kwangju, , South Korea

Inje University Pusan Paik Hospital

Pusan, , South Korea

Hallym University Sacred Heart Hospital,

Pyeongchon, , South Korea

Hallym University Sacred Heart Hospital

Pyeongchon, , South Korea

Asan Medical Center

Seoul, , South Korea

Hangang Sacred Heart Hospital

Seoul, , South Korea

Kyungsang University Hospital

Seoul, , South Korea

Seoul Veterans Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

20070044

Identifier Type: -

Identifier Source: org_study_id