New-DES vs BMS in SVG -1 Year Outcomes (BALTIC)

April 4, 2020 updated by: Wojciech Wańha, Medical University of Silesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

792

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland
        • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
      • Katowice, Poland, 40-635
        • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
      • Kraków, Poland
        • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients undergoing PCI of SVG

Description

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

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SVG PCI
Device: new-DES
with ot without embolic protection device
Device: BMS
with ot without embolic protection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
major adverse cardiac and cerebrovascular event
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 1 year
1 year
myocardial infarction
Time Frame: 1 year
1 year
target vessel revascularization
Time Frame: 1 year
1 year
target lesion revascularization
Time Frame: 1 year
1 year
stroke
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Wojciech Wojakowski

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2008

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 4, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 4, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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