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

NCT01134159 | Completed

• 1 other identifier: REWARDS TLX
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 10

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events,

  A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization

  1 year

Secondary Outcomes (3)

• Stent thrombosis

  1 year

• Target vessel revascularization

  1 year

• Cardiac death

  1 year

Study Arms (2)

Xience V

Those who have only received a Xience V stent

Taxus Liberte

Those who have received only a Taxus Liberte stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Boston Scientific Corporation: collaborator

Study Sites (10)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20913, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, 29575, United States

Location

Heart Clinics Northwest

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 22762711 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 2, 2011

Record last verified: 2011-06

Locations

US (10)