Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01003717
• Lead Sponsor: Rebecca Torguson

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2011-10
• Study Completion: 2013-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States