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
Yonsei University Wonju Hospital
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Korea University Anam Hospital
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
Yonsei University Wonju Hospital
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
  More Information

No publications provided

Responsible Party: Do-Sun Lim/ Interventional Cardiology Cardiovascular Center,, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01365572     History of Changes
Other Study ID Numbers: AN09049-004
Study First Received: May 31, 2011
Last Updated: June 2, 2011
Health Authority: Republic of Korea : Korea Food and Drug Adminstration

Keywords provided by Korea University Anam Hospital:
Drug-eluting stent

ClinicalTrials.gov processed this record on September 16, 2014