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OpenTrials
Completed

NCT Number: NCT00225680

In Stent ELUTES Study

This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Sponsor

Bloomington, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has given informed consent
  • Patient has target lesion in native coronary artery or coronary bypass graft
  • Patient has in-stent restenosis >60%
  • Patient has reference artery diameter 2.7-3.5
  • Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

Exclusion criteria

  • Patient is less than 18 years of age
  • Patient is pregnant or breast feeding
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
  • Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

Treatment and study plan

Drug eluting coronary stent

Device

Primary outcomes

  1. Angiographic target vessel failure (TVF) at follow up

Secondary outcomes

  1. Major adverse events

  2. Target lesion revascularization

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

ELUTES II - In Stent ELUTES Study

Acronym: ELUTES II

Important dates

Study start
2002
Study completion
2005
First posted
Sep 26, 2005
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.