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REWARDS-Angina at Follow up Post Stenting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455817
Recruitment Status : Withdrawn
First Posted : May 28, 2015
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation.

Condition or disease
Rate of Angina

Detailed Description:
The objective of this study is to retrospectively identify the rate of angina (any as well as CCS class III/IV) up to one (1) year following stent implantation. The following drug eluting stents will be evaluated in addition to bare metal stents; Cypher, Taxus Express, Xience V, Resolute and Promus Element. The target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: REWARDS-Angina at Follow up Post Stenting
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Group/Cohort
Cypher
Access rate of angina including degree, post PCI up to 1 year for the Cypher stent.
Taxus Express
Access rate of angina including degree, post PCI up to 1 year for the Taxus Express stent.
Xience V
Access rate of angina including degree, post PCI up to 1 year for the Xience V stent.
Promus Element
Access rate of angina including degree, post PCI up to 1 year for the Promus stent.
Resolute
Access rate of angina including degree, post PCI up to 1 year for the Resolute stent.
Bare metal stents
Access rate of angina including degree, post PCI up to 1 year for bare metal stents.



Primary Outcome Measures :
  1. Rate of Angina [ Time Frame: up to 1 year ]
    post PCI for a variety of DES and BMS



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 male or female, 18 years or older who have received at least one commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents
Criteria

Inclusion Criteria:

  • Patients, male or female, > 18 years of age,
  • Patients who received at least one (1) commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents

Exclusion Criteria:

  • Received more than one type of DES as listed above or both a BMS and DES (as listed above)
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02455817    
Other Study ID Numbers: REWARDS- Angina
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: June 2018
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations