NCT01365572

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 3, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

May 31, 2011

Last Update Submit

June 2, 2011

Conditions

In-stent Arterial Restenosis

Keywords

Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • In-stent neointimal volume index

    9 months on IVUS

Secondary Outcomes (2)

  • Major adverse cardiovascular events

    12 months

  • Efficacy end-point

    9 months

Study Arms (2)

Xience V, drug-eluting stent

ACTIVE COMPARATOR

randomized implantation for DES restenotic lesion

Device: Xiene V stent, Endeavor Resolute stent

Endeavor Resolute, drug-eluting stent

ACTIVE COMPARATOR

randomized implantation for DES restenotic lesion

Device: Xiene V stent, Endeavor Resolute stent

Interventions

Xiene V stent, Endeavor Resolute stentDEVICE

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

Endeavor Resolute, drug-eluting stentXience V, drug-eluting stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yousei Universty Healthcare System

Seoul, South Korea

RECRUITING

Central Study Contacts

Korea University Anam Hospital Ahn, MD, PhD

CONTACT

+82-2-920-5445drcello@kumc.or.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 3, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

June 3, 2011

Record last verified: 2011-03

Locations

KR(1)