New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )

Korea University Anam Hospital292 enrolled

Overview

The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

292

Conditions

In-stent Arterial Restenosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included * Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis * Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm ) * IVUS available lesions * Non-emergent conditions * Patients confirmed about study enrollment and 9 month followup angiogram and IVUS Exclusion Criteria: Lesion \& Procedural exclusion criteria * IVUS unavailable lesion * Restenotic lesions following PCI of de novo lesion like as below; * left main lesions * BMS restenotic lesion * vein graft lesion * Restenotic lesions following 2.25mm DES implantation * Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study) * Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions) * Patients with little possibility of performing follow-up angiogram and IVUS General exclusion criteria * Contraindication to anti-platelet agents \& Bleeding history within prior 3 months * Prior history or current presentation of DES thrombosis * Age over 80 years * Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus, Everolimus * Severe hepatic dysfunction (3 times normal reference values) * Serum creatinine level over 2.0 mg/dL or end-stage renal diseases on dialysis * LVEF less than 30% * Pregnant women or women with potential childbearing * An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 9 months * Life expectancy 1 year

Outcomes

Primary Outcomes

In-stent neointimal volume index

Time frame: 9 months on IVUS

Secondary Outcomes

Major adverse cardiovascular events

Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis

Time frame: 12 months

Efficacy end-point

Efficacy end-point; to evaluate the 9-month binary angiographic restenosis (≥50 percent in-stent diameter stenosis) and late loss, vascular remodeling during follow-up

Time frame: 9 months