Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00225654
NCT00225654CompletedNot Applicable

The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)

Cook Group Incorporated1 site in 1 country192 target enrollmentStarted: January 1, 2000Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
192
Locations
1
Primary Endpoint
Angiographic in-stent % diameter stenosis and late loss at follow up.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Angiographic in-stent % diameter stenosis and late loss at follow up.

Secondary Outcomes

  • Major adverse events
  • Total lesion revascularization

Investigators

Sponsor Class
Industry

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Phase 3
A Trial to Evaluate the Efficacy and Safety of Methoxyetomidate Hydrochloride for Injection (ET-26) for the Induction of General Anesthesia in Elective Surgery SubjectsAnesthesia Induction
NCT06203431Ahon Pharmaceutical Co., Ltd.270
Completed
Phase 3
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque PsoriasisPsoriasisModerate to Severe Plaque Psoriasis
NCT04967508Samsung Bioepis Co., Ltd.503
Unknown
Phase 3
Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 TabletChronic Hepatitis B
NCT02805738Chong Kun Dang Pharmaceutical158
Completed
Phase 2
Efficacy and Safety of Tideglusib in Congenital Myotonic DystrophyCongenital Myotonic Dystrophy
NCT03692312AMO Pharma Limited56
Recruiting
Phase 3
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLCNon-small Cell Lung Cancer
NCT061237543D Medicines (Sichuan) Co., Ltd.390