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

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

Conditions

• In-stent Arterial Restenosis

Interventions

DEVICE

Xiene V stent, Endeavor Resolute stent

for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Sponsors & Collaborators

• Catholic Medical Center

  collaborator OTHER

• KangWon National University Hospital

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Kunyang University Medical center

  collaborator UNKNOWN

• Kyunghee University Medical Center

  collaborator OTHER

• Kyemyeong Univerisity Medical Center

  collaborator UNKNOWN

• Korea University Guro Hospital

  collaborator OTHER

• Kwandong Univerisity Medical Center

  collaborator UNKNOWN

• Kwangjoo Veteran Hospital

  collaborator UNKNOWN

• Eulji University

  collaborator OTHER

• Dankook University

  collaborator OTHER

• Daegoo Catholic Medical College

  collaborator UNKNOWN

• Dong-A University

  collaborator OTHER

• Sejong General Hospital

  collaborator OTHER

• Busan University Medical Center

  collaborator UNKNOWN

• Seoul National University Medical Center

  collaborator UNKNOWN

• Sunkyungwan Univeristy Medical Center

  collaborator UNKNOWN

• Suncheonyang University Medical Center

  collaborator UNKNOWN

• Yonsei University

  collaborator OTHER

• Yongnam University Medical Center

  collaborator UNKNOWN

• Wonkwang University Medical Center

  collaborator UNKNOWN

• Inje Univerisity Medical Center

  collaborator UNKNOWN

• Chonnam National University

  collaborator OTHER

• Chung-Ang University

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Chungnam National University

  collaborator OTHER

• Korea University Anam Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-09-30

Completion

2012-03-31

Countries

• South Korea

Study Locations