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

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 )

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 Overview

• Status: Unknown
• Conditions: In-stent Arterial Restenosis
• Intervention / Treatment: Device: Xiene V stent, Endeavor Resolute stent

• Study Type: Interventional
• Enrollment (Anticipated): 292
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Korea University Anam Hospital Ahn, MD, PhD; Phone Number: +82-2-920-5445; Email: drcello@kumc.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yousei Universty Healthcare System
    • Contact: Yangsoo Jang, MD, PhD; Phone Number: +82-2228-8321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Korea University Guro Hospital; Yonsei University; Kyungpook National University Hospital; Dong-A University; Hallym University Medical Center; Chung-Ang University; Dankook University; Kyunghee University Medical Center; KangWon National University Hospital; Chungnam National University; Chonnam National University; Catholic Medical Center; Eulji University; Kunyang University Medical center; Kyemyeong Univerisity Medical Center; Kwandong Univerisity Medical Center; Kwangjoo Veteran Hospital; Daegoo Catholic Medical College; Bucheon Sejong Hospital; Busan University Medical Center; Seoul National University Medical Center; Sunkyungwan Univeristy Medical Center; Suncheonyang University Medical Center; Yongnam University Medical Center; Wonkwang University Medical Center; Inje Univerisity Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): June 3, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Drug-eluting stent
• Other Study ID Numbers: AN09049-004