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
Device: NEC - Neurovascular Embolization Cover
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Locations near you
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Full eligibility criteria for NCT01054391
Ages eligible for Study
19 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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 pregnant or breastfeeding or unwilling to use birth control for duration of study
Subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study
Subject is unable to comply with study procedures or protocol
Subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
All locations for NCT01054391
Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
Kiel, Germany, 24105
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Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie
Lubeck, Germany, 23538
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View full eligibility
Tris trial is registered with FDA with number: NCT01054391. The sponsor of the trial is Nfocus Neuromedical and it is looking for 10 volunteers for the current phase.
Official trial title: NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study
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