We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01365572
Recruitment Status : Unknown
Verified March 2011 by Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2011
Last Update Posted : June 3, 2011
Information provided by:

May 31, 2011
June 3, 2011
June 3, 2011
January 2010
September 2011   (Final data collection date for primary outcome measure)
In-stent neointimal volume index [ Time Frame: 9 months on IVUS ]
Same as current
No Changes Posted
  • Major adverse cardiovascular events [ Time Frame: 12 months ]
    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 ]
    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
Same as current
Not Provided
Not Provided
New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )
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
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
In-stent Arterial Restenosis
Device: Xiene V stent, Endeavor Resolute stent
for each lesion, randomized either Xience V stent or Endeavor Resolute stent
  • Active Comparator: Xience V, drug-eluting stent
    randomized implantation for DES restenotic lesion
    Intervention: Device: Xiene V stent, Endeavor Resolute stent
  • Active Comparator: Endeavor Resolute, drug-eluting stent
    randomized implantation for DES restenotic lesion
    Intervention: Device: Xiene V stent, Endeavor Resolute stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
March 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Do-Sun Lim/ Interventional Cardiology Cardiovascular Center,, Korea University Anam Hospital
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
  • 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
Not Provided
Korea University Anam Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP