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OpenTrials
Completed

NCT Number: NCT01003977

Registry Experience at the Washington Hospital Center, DES - Xience V

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation

    Time frame: Follow Up

Sponsors and collaborators

Lead sponsor

Rebecca Torguson

Other

Registry information

Official study title

REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)

Acronym: REWARDS XV

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Oct 29, 2009
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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