Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modi… (NCT05774782) | Clinical Trial Compass
CompletedNot Applicable
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
China143 participantsStarted 2023-03-27
Plain-language summary
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 years to 75 years, male or non-pregnant female.
✓. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2).
✓. Parent vessel with a diameter range of 1.75-6.0 mm.
✓. Those who voluntarily participate in the study and sign informed consent form.
Exclusion criteria
✕. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
✕. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
✕. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
✕. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-\[Tris(hydroxymethyl)methyl\] acrylamide (poly-NTMA).
✕. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
✕. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
✕
What they're measuring
1
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 1 year post procedure
Timeframe: 1 year post procedure
2
Major stroke in the territory supplied by the treated artery or neurological death at 1 year post procedure