- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338308
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
-
-
-
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
|
with ot without embolic protection device
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
Collaborators
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.
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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