Phase
Condition
Aneurysm
Treatment
Pipeline™ Flex Embolization Device with Shield Technology™
Clinical Study ID
Ages 22-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has a previously untreated, wide neck, side-wall, intradural aneurysm thatis deemed unfavorable for both surgical clipping and endovascular coiling, asconfirmed on DSA.
Subject has a ruptured intracranial aneurysm with vessel diameter suitable fortreatment 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 writteninformed consent.
Exclusion
Exclusion Criteria:
Subject's vessel characteristics preclude safe endovascular access to the aneurysmto treat with the Pipeline™ Shield Device.
Subject has aneurysm vessel characteristics that would preclude the device fromfully 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 fromthe fundus with placement of the study device.
Subject with intraparenchymal hemorrhage.
Subject is unable to undergo nasogastric/orogastric tube placement prior to deviceplacement.
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 has a target ruptured aneurysm that is thought to be mycotic, includingthose caused by left atrial myxoma, or subject has an active systemic bacterialinfection.
Subject with a requirement for continuous anti-coagulation.
Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenousmalformation).
Subject's target ruptured aneurysm has not been determined by the treating physicianto be the source of SAH.
Subject with known allergy to platinum or cobalt chromium alloy (including the majorelements platinum, cobalt, chromium, nickel or molybdenum).
Subject has a known hypersensitivity to ticagrelor or aspirin.
Subject is unable to undergo DSA or DSA is determined unsuitable by the treatingphysician.
Subject has a serious or life-threatening comorbidity that could confound studyresults.
Subject is at high risk of noncompliance per treating physician due to reasonsincluding but not limited to a history of substance abuse.
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 becomepregnant 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 with a known COVID-19 viral infection, confirmed by testing.
Subject in whom a pre-existing stent is in place in the parent artery at targetaneurysm location.
Study Design
Study Description
Connect with a study center
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Swedish Medical Center
Englewood, Colorado 80113
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Baptist Medical Center Jacksonville
Jacksonville, Florida 32207
United StatesSite Not Available
Jackson Memorial Hospital
Miami, Florida 33136
United StatesSite Not Available
Wellstar Kennestone Hospital
Marietta, Georgia 30060
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky 40506
United StatesSite Not Available
Washington University in Saint Louis
Saint Louis, Missouri 63130
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina
Greenville, South Carolina 29605
United StatesSite Not Available
Semmes Murphey Clinic
Memphis, Tennessee 38120
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
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