New-DES vs BMS in SVG -1 Year Outcomes

NCT ID: NCT04338308

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

792 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-01

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SVG PCI

new-DES

Intervention Type DEVICE

with ot without embolic protection device

BMS

Intervention Type DEVICE

with ot without embolic protection device

Interventions

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new-DES

with ot without embolic protection device

Intervention Type DEVICE

BMS

with ot without embolic protection device

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wojciech Wojakowski

UNKNOWN

Sponsor Role collaborator

Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Wańha

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Gdansk, , Poland

Site Status

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

Katowice, , Poland

Site Status

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

Krakow, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 31003797 (View on PubMed)

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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