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

NCT ID: NCT01003717

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Endeavor

Patients treated with at least 1 Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebecca Torguson

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Torguson

Director, ACRO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Research Institute/Cardiovascular Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

REWARDS EMI

Identifier Type: -

Identifier Source: org_study_id