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Clinical Trials/NCT04338308
NCT04338308
Completed
Not Applicable

New-generation Drug Eluting Stent vs. Bare Metal Stent in Saphenous Vein Graft - 1 Year Outcomes by a Propensity Score Ascertainment (SVG Baltic Registry)

Medical University of Silesia3 sites in 1 country792 target enrollmentFebruary 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Medical University of Silesia
Enrollment
792
Locations
3
Primary Endpoint
major adverse cardiac and cerebrovascular event
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Data regarding the efficacy of the percutaneous coronary intervention (PCI) with new-designed drug-eluting stent (new-DES) vs. bare metal stent (BMS) of saphenous vein grafts (SVG) stenosis is scarce. The primary objective was to compare one-year clinical outcomes of PCI in stenosis of SVG using new-DES vs. BMS in a real-world population. We carried out a multi-center registry comparing new-DES with BMS in all consecutive patients undergoing PCI of SVG. The primary composite endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 1 year.

Registry
clinicaltrials.gov
Start Date
February 1, 2008
End Date
March 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wojciech Wańha

MD, PhD

Medical University of Silesia

Eligibility Criteria

Inclusion Criteria

  • patients after CABG with significant SVG stenosis referred for PCI

Exclusion Criteria

  • patients who had both types of stents implanted in the same procedure
  • patients with the old-DES
  • patients who had PCI of other vascular territories during the same procedure

Outcomes

Primary Outcomes

major adverse cardiac and cerebrovascular event

Time Frame: 1 year

Secondary Outcomes

  • target lesion revascularization(1 year)
  • death(1 year)
  • myocardial infarction(1 year)
  • target vessel revascularization(1 year)
  • stroke(1 year)

Study Sites (3)

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