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Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES) (P-REWARDS)

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ClinicalTrials.gov Identifier: NCT01003795
Recruitment Status : Withdrawn (Not Funded)
First Posted : October 29, 2009
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Condition or disease
Coronary Artery Disease

Detailed Description:
Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Promus® Stent for at least 1 year post initial stent implantation.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)
Study Start Date : October 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Promus
Patients treated with at least one Promus, everolimus-eluting, Stent



Primary Outcome Measures :
  1. Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation [ Time Frame: Follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with at least one Promus, everolimus-eluting, Stent at the Washington Hospital Center.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003795


Locations
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United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Principal Investigator: Ron Waksman, MD Medstar Research Institute/Cardiovascular Research Institute
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01003795    
Other Study ID Numbers: P REWARDS
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases