Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Medstar Research Institute
Start date August 2009
End date September 2011
Trial size 1000 participants
Trial identifier NCT01003977, REWARDS XV

Summary

Single center registry of patients who have received a Xience V everolimus-eluting stent at the Washington Hospital Center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients treated with a Xience V everolimus-eluting stent

Primary Outcomes

Measure
Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation
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 who received at least one Xience V drug-eluting stent at the Washington Hospital Center Exclusion Criteria: - Patients who received another type of DES (other than Xience V) or a bare metal stent at the time of initial Xience V stent implantation

Additional Information

Official title REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)
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). The everolimus eluting, Xience V 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 Xience V® Stent for at least 1 year 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.