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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-03-31

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

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Detailed Description

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Conditions

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In-stent Arterial Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Xience V, drug-eluting stent

randomized implantation for DES restenotic lesion

Group Type ACTIVE_COMPARATOR

Xiene V stent, Endeavor Resolute stent

Intervention Type DEVICE

for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Endeavor Resolute, drug-eluting stent

randomized implantation for DES restenotic lesion

Group Type ACTIVE_COMPARATOR

Xiene V stent, Endeavor Resolute stent

Intervention Type DEVICE

for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Interventions

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Xiene V stent, Endeavor Resolute stent

for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Intervention Type DEVICE

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

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No