Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V

NCT ID: NCT01134159

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Xience V

Those who have only received a Xience V stent

No interventions assigned to this group

Taxus Liberte

Those who have received only a Taxus Liberte stent

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older, both genders
* Underwent PCI with Taxus Liberte (alone) or Xience (alone)

Exclusion Criteria

* Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure
* Received both Taxus-Liberte and Xience-V during the same index procedure
* Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Cardiovascular Research Institute/ Medstar Health Research Institute

Principal Investigators

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Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Washington Adventist Hospital

Takoma Park, Maryland, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, United States

Site Status

Heart Clinics Northwest

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Waksman R, Ghali M, Goodroe R, Ryan T, Turco M, Ring M, McGarry T, Dobies D, Shammas N, Steinberg DH, Swymelar S, Kaneshige K, Torguson R. Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial). Am J Cardiol. 2012 Oct 15;110(8):1119-24. doi: 10.1016/j.amjcard.2012.05.050. Epub 2012 Jul 3.

Reference Type DERIVED
PMID: 22762711 (View on PubMed)

Other Identifiers

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REWARDS TLX

Identifier Type: -

Identifier Source: org_study_id

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