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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01003977

Acronym

REWARDS XV

Enrollment

6069

Registered

2009-10-29

Start date

2009-08-31

Completion date

2013-09-30

Last updated

2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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.

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, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation	Follow Up

Countries

United States

Outcome results