Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Completed · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Key facts

Study ID

NCT02186561

Run by

Medtronic Neurovascular Clinical Affairs

People needed

197

Starts

2014-07-24

Expected to finish

2018-12-13

Last updated by the study team

2019-12-27

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
• Age 22-80 years.
• Subject has a target intracranial aneurysm (IA) located in the:
• Internal carotid artery (up to the carotid terminus) OR
• Vertebral artery segment up to and including the posterior inferior cerebellar artery
• Subject has a target IA that is ≤ 12 mm.
• Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
• Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
• Subject has a pre-procedure PRU value between 60-200.

You may not qualify if…

• Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
• Subarachnoid hemorrhage in the past 30 days.
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
• Major surgery in the last 30 days.
• History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
• Any known contraindication to treatment with the Pipeline™ device, including:
• Stent is in place in the parent artery at the target IA location
• Contraindication to dual antiplatelet therapy
• Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled).
• Known severe allergy to platinum or cobalt/chromium alloys.
• Evidence of active infection at the time of treatment (e.g., fever with temperature >38°C and/or WBC >1.5 109/L).
• The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
• Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
• Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.

Where it is running

• Radiology Imaging Associates — Englewood, Colorado, United States
• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Florida Hospital — Winter Park, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Baptist Physicians Lexington — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts University Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Kaleida Health/University of Buffalo — Buffalo, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• St. Luke's Health Baylor College of Medicine — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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