Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES) (P-REWARDS)

P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)

Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease

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). The everolimus eluting stents have shown very promising results in randomized clinical trials, 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 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 Promus® Stent for at least 1 year post initial stent implantation.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with at least one Promus, everolimus-eluting, Stent at the Washington Hospital Center.

Description

Inclusion Criteria:

• Patients, male or female, >18 years of age
• Patients who received at least one Promus drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Promus; Patients treated with at least one Promus, everolimus-eluting, Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation	Follow up

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Ron Waksman, MD, Medstar Research Institute/Cardiovascular Research Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: P REWARDS