NCT01794065

Brief Summary

This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

February 14, 2013

Last Update Submit

August 8, 2014

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

  • Stent length

    The primary endpoint of this study will be to assess the overall change in stent length post deployment by intravascualar ultrasound (IVUS) between the 5 stent groups.

    1 day

Secondary Outcomes (1)

  • IVUS stent length

    1 day

Study Arms (5)

Cypher

100 patients who have received a Cypher stent during their coronary intervention

Taxus Express

100 patients who have received a Taxus Express stent during their coronary intervention

Endeavor

100 patients who have received an Endeavor stent during their coronary intervention

Promus/Xience V

100 patients who have received a Promus/Xience V stent during their coronary intervention

Promus Element

100 patients who have received a Taxus Element stent during their coronary intervention

Eligibility Criteria

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

Patients who are scheduled to receive a Promus Element stent implant, and have de novo coronary lesions.

You may qualify if:

  • Patients, male or female, 18 years or older;
  • Patients with de-novo coronary lesions and slated to receive a Promus Element stent;
  • Patients who are slated to undergo IVUS after stent deployment during implantation procedure

You may not qualify if:

  • Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure;
  • Patients with in-stent restenosis;
  • Patients who had IVUS imaging attained with manual pullback.

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

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ron Waksman, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 18, 2013

Study Start

October 1, 2012

Primary Completion

January 1, 2015

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(1)