Study Results
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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WITHDRAWN
OBSERVATIONAL
2018-02-28
2024-01-31
Brief Summary
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Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR, assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days, 6 months, 1 year, 3 years, and 5 years, if available.
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Detailed Description
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The outcomes associated with ISR highlight the fact that this is by no means a benign process and studies report MI rates as high as 19.4% with one study demonstrating a total rate of death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS) has an independent effect on major adverse cardiac events. The emergence of fully bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the long-term structural and functional effects on the coronary vessel seen with implantation of a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time. The long-term benefits of such technology have yet to be fully assessed. However, based on literature outlining the complicated course of ISR in short-term and that seen in the bare metal stent era, it is projected that complete resorbtion of the vascular scaffold should improve long-term outcomes of patients with ischemic heart disease.
Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are not completely understood. The goal of this particular study is to retrospectively evaluate the long-term impact of ISR over a 10-year period in current contemporary DES. The data can be compared to de novo coronary artery lesions with similar characteristics and complexity to highlight the significant differences in the clinical course of each disease. Ultimately, the investigators will hopefully demonstrate the need for improvement in this arena, which the BVS will potentially provide.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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PCI with Commercially available DES
Patients who have undergone PCI and received a commercially available drug eluting stent
No interventions assigned to this group
Stent Types
the stent types for angina classification at follow up
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients who received at least one (1) commercially available Drug Eluting Stent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Locations
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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REWARDS-ISR
Identifier Type: -
Identifier Source: org_study_id
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