PARADIGM

Summary

Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system

 

Authors               

Piotr Musialek1*, MD, DPhil; Adam Mazurek1, MD; Mariusz Trystula2, MD, PhD; Anna Borratynska3, MD, PhD; Agata Lesniak-Sobelga1, MD, PhD; Malgorzata Urbanczyk4, MD; R.Pawel Banys4, MSc; Andrzej Brzychczy2, MD, PhD; Wojciech Zajdel5, MD, PhD; Lukasz Partyka6, MD, PhD; Krzysztof Zmudka5, MD, PhD; Piotr Podolec1, MD, PhD

 

Results

A prospective, all-referral-study of 101 symptomatic and high-risk asymptomatic patients treated with CGuard™ EPS.  Independent neurologist evaluation before the stenting, at 48 hours and 30 days was performed.  At 30 days, MACE was 0% and implantation success was 100%.

 

FU and Comments: This is a real All-comer study where the operator has to use CGuard™ by protocol without the possibility to exclude patients’ due to the lesion complexity (as tortuosity, calcification etc).

At 1y follow-up the results remain excellent showing 0% Major adverse cardiac or neurological effects (MACNE).  Also shown, 100% of vessel patency and a single case of intrastent restenosis (1%) and no postprocedural External Carotid occlusions.

 

Due to the overwhelming clinical results of the study, it will continue to include up to 250 patients in order to obtain a more robust statistical database.