- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455817
REWARDS-Angina at Follow up Post Stenting
October 8, 2020 updated by: Medstar Health Research Institute
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Angina
Time Frame: up to 1 year
|
post PCI for a variety of DES and BMS
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
May 26, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (Estimate)
May 28, 2015
Study Record Updates
Last Update Posted (Actual)
October 12, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REWARDS- Angina
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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