NCT04338308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
792

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

7.7 years

First QC Date

April 4, 2020

Last Update Submit

April 4, 2020

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary interventionSaphenous vein graftNew generation drug-eluting stentBare metal stent

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiac and cerebrovascular event

    1 year

Secondary Outcomes (5)

  • death

    1 year

  • myocardial infarction

    1 year

  • target vessel revascularization

    1 year

  • target lesion revascularization

    1 year

  • stroke

    1 year

Study Arms (1)

SVG PCI

Device: new-DESDevice: BMS

Interventions

new-DESDEVICE

with ot without embolic protection device

SVG PCI
BMSDEVICE

with ot without embolic protection device

SVG PCI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients undergoing PCI of SVG

You may qualify if:

  • patients after CABG with significant SVG stenosis referred for PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Gdansk, Poland

Location

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

Katowice, 40-635, Poland

Location

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

Krakow, Poland

Location

Related Publications (1)

  • Wanha W, Mielczarek M, Roleder T, Ladzinski S, Milewski M, Gilis-Malinowska N, Chmielecki M, Ciecwierz D, Bachorski W, Kunik P, Trznadel A, Mecka K, Genc A, Januszek R, Paczek P, Dziewierz A, Bartus S, Gruchala M, Smolka G, Dudek D, Navarese EP, Ochala A, Jaguszewski M, Wojakowski W. New-generation drug eluting stent vs. bare metal stent in saphenous vein graft - 1 year outcomes by a propensity score ascertainment (SVG Baltic Registry). Int J Cardiol. 2019 Oct 1;292:56-61. doi: 10.1016/j.ijcard.2019.04.022. Epub 2019 Apr 11.

    PMID: 31003797BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 8, 2020

Study Start

February 1, 2008

Primary Completion

October 1, 2015

Study Completion

March 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

PL(3)