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The ELUTES Clinical Trial (ELUTES I)

Cook Group logo

Cook Group

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: coronary stent

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
  • Patient must be an acceptable candidate for coronary artery bypass surgery.
  • Patient or legal guardian must have signed informed consent.
  • Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion criteria

  • Patient must be less than 18 years old.
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
  • Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
  • Women of child bearing potential.
  • Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
  • Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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