The Promus Element Rewards Study

NCT ID: NCT01794065

Last Updated: 2014-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cypher

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

No interventions assigned to this group

Taxus Express

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

No interventions assigned to this group

Endeavor

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

No interventions assigned to this group

Promus/Xience V

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

No interventions assigned to this group

Promus Element

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Medstar Washington Hospital Center

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

Site Status

Countries

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United States

Other Identifiers

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REWARDS PE

Identifier Type: -

Identifier Source: org_study_id

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