Pipeline for Uncoilable or Failed Aneurysms (PUFS)

Medtronic

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Pipeline Embolization Device (PED)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777088

COVPUFS0398

Details and patient eligibility

About

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

Full description

Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

Enrollment: 108 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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 Institutional Review Board (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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Pipeline

Experimental group

Description:

Placement of Pipeline Embolization Device in the parent artery at the aneurysm location

Treatment:

Device: Pipeline Embolization Device (PED)