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

NCT ID: NCT01003977

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6069 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Xience V

Patients treated with a Xience V everolimus-eluting stent

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebecca Torguson

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Torguson

Director, ACRO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Research Institute/Cardiovascular Research Institute

Locations

Washington Hospital Center

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

Countries

United States

Other Identifiers

REWARDS XV

Identifier Type: -

Identifier Source: org_study_id