Clinical trial NCT00777088: Pipeline for Uncoilable or Failed Aneurysms
Official title: Pipeline for Uncoilable or Failed Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: neurovascular embolization
therapeutic embolization
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
timeFrame: 180-days and 5-years
measure: Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
timeFrame: 180 days
Secondary outcomes:
measure: Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
timeFrame: 1 Year
measure: Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
timeFrame: 3 years
measure: Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
timeFrame: 5 years
measure: Stenosis of the Parent Artery in PED at 3 Years
timeFrame: 3-years
measure: Stenosis of the Parent Artery in PED at 5 Years
timeFrame: 5-years
measure: Number of Participants With Device-Related Adverse Events at 3 Years
timeFrame: 3 years
measure: Number of Participants With Device-related Adverse Events at 5 Years
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Winfield
country: United States
facility: Central Du Page Hospital
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Budapest
country: Hungary
facility: National Institute of Neurosurgery
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: New York University
name: Tibor Bescke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
citation: Sahlein DH, Fouladvand M, Becske T, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Kallmes DF, Nelson PK. Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results. J Neurosurg. 2015 Oct;123(4):897-905. doi: 10.3171/2014.12.JNS141777. Epub 2015 Jul 10.