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Clinical Trials/NCT01003977
NCT01003977CompletedNot Applicable

REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)

Rebecca Torguson1 site in 1 country6,069 target enrollmentStarted: August 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
6,069
Locations
1
Primary Endpoint
Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Single center registry of patients who have received a Xience V everolimus-eluting stent at the Washington Hospital Center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed Description

Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting, Xience V stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Xience V® Stent for at least 1 year post initial stent implantation.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

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

Inclusion Criteria

  • •Patients, male or female, >18 years of age
  • •Patients who received at least one Xience V drug-eluting stent at the Washington Hospital Center

Exclusion Criteria

  • •Patients who received another type of DES (other than Xience V) or a bare metal stent at the time of initial Xience V stent implantation

Outcomes

Primary Outcomes

Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation

Time Frame: Follow Up

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Rebecca Torguson
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rebecca Torguson

Director, ACRO

Medstar Health Research Institute

Study Sites (1)

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Registry Experience at the Washington... | Clinical Trial