Skip to main content
OpenTrials
Completed

NCT Number: NCT04338308

New-DES vs BMS in SVG -1 Year Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland, Gdansk, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

new-DES

Device

with ot without embolic protection device

BMS

Device

with ot without embolic protection device

Primary outcomes

  1. major adverse cardiac and cerebrovascular event

    Time frame: 1 year

Secondary outcomes

  1. death

    Time frame: 1 year

  2. myocardial infarction

    Time frame: 1 year

  3. target vessel revascularization

    Time frame: 1 year

  4. target lesion revascularization

    Time frame: 1 year

  5. stroke

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Wojciech Wojakowski

Registry information

Official study title

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

Acronym: BALTIC

Important dates

Study start
2008
Primary completion
2015
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.