Carotid Artery Aneurysm Clinical Trial
Official title:
Prospective Observational Study of CGuard MicroNet Covered Stent System Use as a Flow Diverter in the Endovascular Exclusion of Carotid Artery Aneurysms. (CGuard Divert-and-HEAL C-HEAL)
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.
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 implicating the risk of thrombus formation in the aneurysm cavity, and
subsequent ischemic stroke from distal embolization. Another important clinical problem
related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and
increasing dimensions of CAA institute unquestioned indications for the CAA treatment.
Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial
nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion
were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization
with coils were applied. However, covered stents were demonstrated to increase the restenosis
risk, and other complications such as CAA neck endo-leak.
Newer technique involves the flow diversion by implantation of stent in dense-structured
stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow
dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and
occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was
related to necessity of double stent load and increased restenosis risk (double metal layer).
These issues were addressed only recently by the double layer mesh stents that demonstrate
natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered
with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition,
in low flow conditions MicroNet can act as the flow diverter. These stents are routinely
implanted in elevated risk plaques in high reference centers in Europe.
Several published observations indicate the CGuard stent also demonstrates flow-diverting
capabilities, but the systematic observation of such application was not performed.
C-HEAL is a non-randomized, single arm, open label academic observational study of CGuard
stent implantation in carotid arteries in patients with symptomatic, dissecting or enlarging
carotid artery aneurysm. Procedures are performed according to the center routine, with
application of proximal or distal embolic protection device (if feasible), and standard
pharmacotherapy according to the current guidelines.
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