Comparison Between Drug-Eluting Stents for the Treatment of the Diffuse Type In-Stent Restenosis After Drug-Eluting Stents Implantation: Sirolimus-Eluting vs. Paclitaxel-Eluting Stents

Seung-Jung Park14 sites in 1 country60 target enrollmentMarch 2007

ConditionsIn-stent Restenosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: In-stent Restenosis
Sponsor: Seung-Jung Park
Enrollment: 60
Locations: 14
Primary Endpoint: Binary in-segment angiographic restenosis
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

October 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

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

CardioVascular Research Foundation, Korea

Eligibility Criteria

Inclusion Criteria

•The patient must be at least 18 years of age.
•Restenosis after drug-eluting stents (\>50% by visual estimate)
•Lesion length ≥ 10 mm (diffuse type ISR)
•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
•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

•The patient has a known hypersensitivity or contraindication to any of the following medications:
•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).
•Systemic (intravenous) Sirolimus use within 12 months.
•Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
•History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
•Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
•Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.

Outcomes

Primary Outcomes

Binary in-segment angiographic restenosis

Time Frame: at 9 months angiographic follow-up

Secondary Outcomes

The composite of death, myocardial infarction, and target-vessel revascularization(in-hospital, 1 month, and 9 months after index procedure)
stent thrombosis(in-hospital, 1 month, and 9 months after index procedure)
Late luminal loss(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(during the hospital stay)