Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Medstar Research Institute
Start date October 2009
End date October 2011
Trial size 120 participants
Trial identifier NCT01003717, REWARDS EMI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients treated with at least 1 Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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: - N/A

Additional Information

Official title REWARDS-EMI (Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction)
Principal investigator Ron Waksman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Medstar Research Institute.