Clinical trial NCT01134159: Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V
Official title: Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2010-05-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients male or female, 18 years or older whom have undergone PCI with either Taxus Liberte or Xience V

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Major adverse cardiac events,
timeFrame: 1 year
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 1 year
measure: Target vessel revascularization
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.