NCT03008772

Brief Summary

To define the long-term incidence and frequency of ISR follow DES implantation. Compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and DES ISR. Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR, assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days, 6 months, 1 year, 3 years, and 5 years, if available.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

December 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4.9 years

First QC Date

December 21, 2016

Last Update Submit

October 15, 2020

Conditions

In-Stent Coronary Artery Restenosis

Outcome Measures

Primary Outcomes (1)

  • Rate of Instent Restenosis

    Up to 5 years

Study Arms (2)

PCI with Commercially available DES

Patients who have undergone PCI and received a commercially available drug eluting stent

Stent Types

the stent types for angina classification at follow up

Eligibility Criteria

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

All study subjects will be identified retrospectively. Patients who have undergone PCI and received a commercially available drug eluting stent as listed above. These patients will be compared between the stent types for angina classification at follow up.

You may qualify if:

  • Patients, male or female, \> 18 years of age,
  • Patients who received at least one (1) commercially available Drug Eluting Stent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

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

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 2, 2017

Study Start

February 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)