New-DES vs BMS in SVG -1 Year Outcomes

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: new-DES; Device: BMS

• Registration Number: NCT04338308
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-01
• Primary Completion: 2015-10-01
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-04
• Last Update Submitted: 2020-04-04
• Study First Posted: 2020-04-08
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SVG PCI	new-DES	-
SVG PCI	BMS	-

Primary Outcome Measures

Name	Time	Method
major adverse cardiac and cerebrovascular event	1 year

Secondary Outcome Measures

Name	Time	Method
stroke	1 year
target lesion revascularization	1 year
death	1 year
myocardial infarction	1 year
target vessel revascularization	1 year

Trial Locations

Locations (3)

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 🇵🇱 Gdańsk, Poland

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 🇵🇱 Kraków, Poland

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