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

Study Overview
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Brief Summary
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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

Official Title
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Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of EverolimuS-Eluting Versus ZoTarolimus-Eluting steNTs for In-Stent Restenosis(ISR) Lesions: Volumetric Analysis With Intravascular Ultrasound(IVUS) : Phase IV Multicenter Trial ( RESTENT-ISR Trial )

Conditions
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In-stent Arterial Restenosis

Intervention / Treatment
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* Device: Xiene V stent, Endeavor Resolute stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xience V, drug-eluting stent<br>randomized implantation for DES restenotic lesion | Device: Xiene V stent, Endeavor Resolute stent<br>* for each lesion, randomized either Xience V stent or Endeavor Resolute stent<br>|
| Active Comparator: Endeavor Resolute, drug-eluting stent<br>randomized implantation for DES restenotic lesion | Device: Xiene V stent, Endeavor Resolute stent<br>* for each lesion, randomized either Xience V stent or Endeavor Resolute stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent neointimal volume index |  | 9 months on IVUS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stent