NCT01003977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,069

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2.1 years

First QC Date

October 20, 2009

Last Update Submit

December 27, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

    Follow Up

Study Arms (1)

Xience V

Patients treated with a Xience V everolimus-eluting stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with a Xience V, everolimus-eluting, Stent at the Washington Hospital Center.

You may qualify if:

  • Patients, male or female, \>18 years of age
  • Patients who received at least one Xience V drug-eluting stent at the Washington Hospital Center

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

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

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ron Waksman, MD

    Medstar Research Institute/Cardiovascular Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, ACRO

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 29, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2013

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

US(1)