Carotid Artery Aneurysm Treatment Using CGuard Divert-And-Heal Strategy
Poland25 participantsStarted 2020-04-27
Plain-language summary
Non-randomized, single arm, open label, academic observational study of CGuard MicroNet covered stent system use to achieve endovascular lumen reconstruction in carotid artery aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic).
Jagiellonian University Medical College research project.
Who can participate
Age range18 Years
SexALL
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General
Inclusion Criteria:
* Patients older than 18 years, eligible for endovascular carotid artery aneurysm treatment with Micronet covered stent per Vascular Team evaluation, according to local standards
* Written, informed consent to participate
* Agreement to attend protocol required (standard) follow up visits and examinations
Exclusion Criteria:
* Preferred treatment other than stenting (surgery or conservative treatment / observation) per Vascular Team evaluation
* Life expectancy \<1 year (e.g. active neoplastic disease).
* Chronic kidney disease with creatinine \> 3.0 mg/dL.
* Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
* Pregnancy (positive pregnancy test)
* Coagulopathy.
* History of uncontrolled contrast media intolerance
Angiographic
Inclusion Criteria:
* Carotid artery aneurysm confirmed on angiography - symptomatic, dissected or enlarging
* Aneurysm eligible for endovascular treatment per Vascular Team evaluation (according to current standards, guidelines and study center practice)
Exclusion Criteria:
* Unsuccessful true lumen engagement
* Aneurysm neck anatomy precluding healthy-to-healthy coverage with stent
* Anatomic variants precluding stent implantation
* Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion