Pipeline for Uncoilable or Failed Aneurysms

NCT ID: NCT00777088

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-09-22

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pipeline

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

Group Type: EXPERIMENTAL

Pipeline Embolization Device (PED)

Intervention Type: DEVICE

1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Interventions

Pipeline Embolization Device (PED)

1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibor Bescke, MD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Rush University

Chicago, Illinois, United States

Central Du Page Hospital

Winfield, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University St. Louis

St Louis, Missouri, United States

University of Buffalo

Buffalo, New York, United States

New York University

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

National Institute of Neurosurgery

Budapest, , Hungary

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

United States; Hungary; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 27739944 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26162031 (View on PubMed)

Other Identifiers

COVPUFS0398

Identifier Type: -

Identifier Source: org_study_id