Status:
UNKNOWN
Carotid Artery Aneurysm Treatment Using CGuard Divert-And-Heal Strategy
Lead Sponsor:
John Paul II Hospital, Krakow
Conditions:
Carotid Artery Aneurysm
Eligibility:
All Genders
18+ years
Brief 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 indicatio...
Detailed Description
Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the carotid artery impli...
Eligibility Criteria
Inclusion
- General
- 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
- 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)
Key Trial Info
Start Date :
April 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04434456
Start Date
April 27 2020
End Date
May 31 2022
Last Update
September 2 2020
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, Poland, 31-202