This trial is active, not recruiting.

Condition intracranial aneurysm
Treatment pipeline embolization device (ped)
Sponsor ev3
Start date October 2008
End date April 2016
Trial size 135 participants
Trial identifier NCT00777088, COVPUFS0398


To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
pipeline embolization device (ped)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Primary Outcomes

Occurrence of ipsilateral stroke or neurovascular death.
time frame: 5 years

Secondary Outcomes

Rate of complete target aneurysm occlusion
time frame: 3 and 5 years
Incidence of device-related adverse events
time frame: 3 and 5 years
Stenosis of the parent artery in PED
time frame: 3 and 5 years

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

Inclusion Criteria: - Age 21 to 75 years, inclusive - Patient has a single target IA in the anterior or posterior circulation that: a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA - Subject has provided written informed consent using the IRB-approved consent form - Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements Exclusion Criteria: - More than one IA requires treatment in the next 6 months - Subarachnoid hemorrhage from target IA in the past 60 days - Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) - Irreversible bleeding disorder - Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction - Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications - Stent in place at the target IA - Contraindication to CT scan or MRI - Allergy to contrast used in angiography that cannot be medically controlled - Known severe allergy to platinum or cobalt/chromium alloys - Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL) - Woman of child-bearing potential who cannot provide a negative pregnancy test - Evidence of active infection at the time of treatment - Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis) - Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days - Extracranial stenosis greater than 50% in the carotid artery for anterior circulation aneurysms - Intracranial stenosis greater than 50% in the treated vessel

Additional Information

Official title Pipeline for Uncoilable or Failed Aneurysms
Principal investigator Tibor Bescke, MD
Description Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by ev3.