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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Korea University Anam Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Catholic Medical Center

Kangwon University Medical Center

Kyungbook Univeristy Medical Center

Kunyang University Medical center

Kyunghee University Medical Center

Kyemyeong Univerisity Medical Center

Korea University Guro Hospital

Kwandong Univerisity Medical Center

Kwangjoo Veteran Hospital

Eulji University

Dankook University

Daegoo Catholic Medical College

Dong-A University

Bucheon Sejong Hospital

Busan University Medical Center

Seoul National University Medical Center

Sunkyungwan Univeristy Medical Center

Suncheonyang University Medical Center

Yonsei University Medical Center

Yonsei University

Yongnam University Medical Center

Wonkwang University Medical Center

Inje Univerisity Medical Center

Chonnam National University

Chung-Ang University

Hallym University Medical Center

Chungnam National University

Information provided by:

Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT01365572

First received: May 31, 2011

Last updated: June 2, 2011

Last verified: March 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
In-stent Arterial Restenosis	Device: Xiene V stent, Endeavor Resolute stent	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	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 )

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:

In-stent neointimal volume index [ Time Frame: 9 months on IVUS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Major adverse cardiovascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis
Efficacy end-point [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	292
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365572

Contacts

Contact: Korea University Anam Hospital Ahn, MD, PhD

+82-2-920-5445

drcello@kumc.or.kr

Locations

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

Sponsors and Collaborators