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

Korea University

Status and phase: Unknown; Phase 4

Conditions: In-stent Arterial Restenosis

Treatments: Device: Xiene V stent, Endeavor Resolute stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01365572

AN09049-004

Details and patient eligibility

About

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

Enrollment: 292 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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292 participants in 2 patient groups

Xience V, drug-eluting stent

Active Comparator group

Description:

randomized implantation for DES restenotic lesion

Treatment:

Device: Xiene V stent, Endeavor Resolute stent

Endeavor Resolute, drug-eluting stent

Active Comparator group

Description:

randomized implantation for DES restenotic lesion

Treatment:

Device: Xiene V stent, Endeavor Resolute stent