The Promus Element Rewards Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01794065
First received: February 14, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition
Coronary Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Promus Element Rewards Study

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Stent length [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • IVUS stent length [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The secondary endpoints of this analysis will be to detect the occurrence of a 10% change in stent length by IVUS as compared to the labeled stent length.


Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794065

Locations
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01794065     History of Changes
Other Study ID Numbers: REWARDS PE
Study First Received: February 14, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014