Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasi… (NCT01054391) | Clinical Trial Compass
UnknownNot Applicable
Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae
Germany10 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
Who can participate
Age range19 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively
* Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula
* Parent artery reference diameter is \>2.5mm and \<4.5mm
* Subject is an adult above age 18
* Subject is able to provide written Informed Consent
* Subject has good general health, is clinically stable, and is considered to be mentally sound
* Subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial.
Exclusion Criteria:
* Subject has subarachnoid hemorrhage (SAH) \< three (3) weeks prior to NEC procedure
* Subject has had prior stenting of the target aneurysm.
* Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.
* Subject has collagen vascular disease.
* Subject has a contraindication to angiography (e.g., serum creatinine level \> 2.5 mg/dL)
* Subject has evidence of active infection at the time of treatment
* Subject is preg…
What they're measuring
1
Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography
Timeframe: 6 month follow-up
2
Proportion of subjects who experience neurologic death or ipsilateral stroke