Clinical trial NCT01365572: New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )
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 )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: In-stent Arterial Restenosis
Keywords: Drug-eluting stent
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Catholic Medical Center
name: KangWon National University Hospital
name: Kyungpook National University Hospital
name: Kunyang University Medical center
name: Kyunghee University Medical Center
name: Kyemyeong Univerisity Medical Center
name: Korea University Guro Hospital
name: Kwandong Univerisity Medical Center
name: Kwangjoo Veteran Hospital
name: Eulji University
name: Dankook University
name: Daegoo Catholic Medical College
name: Dong-A University
name: Sejong General Hospital
name: Busan University Medical Center
name: Seoul National University Medical Center
name: Sunkyungwan Univeristy Medical Center
name: Suncheonyang University Medical Center
name: Yonsei University
name: Yongnam University Medical Center
name: Wonkwang University Medical Center
name: Inje Univerisity Medical Center
name: Chonnam National University
name: Chung-Ang University
name: Hallym University Medical Center
name: Chungnam National University
First posted: 2011-06-03
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: In-stent neointimal volume index
timeFrame: 9 months on IVUS
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
measure: Efficacy end-point
timeFrame: 9 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yousei Universty Healthcare System
Study officials:
References: