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

Phase 4

• Conditions: In-stent Arterial Restenosis
• Interventions: Device: Xiene V stent, Endeavor Resolute stent

• Registration Number: NCT01365572
• Lead Sponsor: Korea University Anam Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2011-03
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-02
• Last Update Submitted: 2011-06-02
• Study First Posted: 2011-06-03
• Last Update Posted: 2011-06-03
• Primary Completion: 2011-09
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endeavor Resolute, drug-eluting stent	Xiene V stent, Endeavor Resolute stent	randomized implantation for DES restenotic lesion
Xience V, drug-eluting stent	Xiene V stent, Endeavor Resolute stent	randomized implantation for DES restenotic lesion

Primary Outcome Measures

Name	Time	Method
In-stent neointimal volume index	9 months on IVUS

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	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	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

Trial Locations

Locations (1)

Yousei Universty Healthcare System; 🇰🇷 Seoul, Korea, Republic of