EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

A vizsgálat adatai

Ki végzi

Medtronic Neurovascular Clinical Affairs

Azonosító

NCT04391803

A regiszteradat frissítve

2026. január 27.

Eredeti leírás

The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.A teljes eredeti leírásKevesebb

The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.

Bevonási feltételek: Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA; Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device; Subject is ≥ 22 and ≤ 80 years of age; Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3; Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.

Kizáró feltételek: Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement; Subject with intraparenchymal hemorrhage; Subject has a target ruptured aneurysm that is thought to be mycotic, including those caused by left atrial myxoma, or subject has an active systemic bacterial infection; Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation); Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum); Subject has a known hypersensitivity to ticagrelor or aspirin; Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse; Subject with a known COVID-19 viral infection, confirmed by testing; Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device; Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement; Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device; Subject has a pre-morbid mRS >2; Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm; Subject with a requirement for continuous anti-coagulation; Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH; Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician; Subject has a serious or life-threatening comorbidity that could confound study results; Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months; Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study; Subject is participating in another clinical study at the time of enrollment; Presumed septic embolus, or suspicion of microbial superinfection; Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.

ClinicalTrials.gov NCT04391803