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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01003717
First received: October 20, 2009
Last updated: March 28, 2013
Last verified: March 2013

October 20, 2009
March 28, 2013
October 2009
October 2011   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01003717 on ClinicalTrials.gov Archive Site
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Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction
REWARDS-EMI (Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Patients who receive at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome, at the Washington Hospital Center.

Coronary Artery Disease
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Endeavor
Patients treated with at least 1 Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
October 2013
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01003717
REWARDS EMI
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Medstar Research Institute/Cardiovascular Research Institute
Medstar Research Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP