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Clinical Trials/NCT01003717
NCT01003717CompletedNot Applicable

REWARDS-EMI (Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction)

Rebecca Torguson1 site in 1 country120 target enrollmentStarted: October 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Evaluation of Major Adverse Cardiac Events following implantation of at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome

Study Overview

Brief Summary

Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center, with the aim of assessing clinical success and safety at 30 days, 6 months and annually for up to 3 years post Endeavor Stent 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).Zotarolimus-eluting stents have shown promising results in randomized clinical trails, 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 short-term and 1 year 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 Endeavor® Stent as primary treatment for ACS for up to 3 years 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 presenting with acute coronary syndrome (ACS), where ACS is defined as ST segment deviation of >1mm or an elevation of the isoenzymes greater than 2x upper limit of normal
  • Patients who received at least one Endeavor drug-eluting stent at the Washington Hospital Center

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluation of Major Adverse Cardiac Events following implantation of at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome

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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