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

Coronary Artery Disease Clinical Trial

— REWARDS XV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003977
• Other study ID #: REWARDS XV
• Status: Completed
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: December 2019
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6069
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rebecca Torguson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation		Follow Up