Pipeline for Uncoilable or Failed Aneurysms

NCT00777088 | Completed Results

• 1 other identifier: COVPUFS0398
• Study Type: interventional
• Target: 108
• Locations: 3 countries
• Sites: 10

Brief Summary

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

Conditions

Intracranial Aneurysm

Keywords

neurovascular embolization; therapeutic embolization

Outcome Measures

Primary Outcomes (2)

• Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.

  The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.

  180-days and 5-years

• Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.

  The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

  180 days

Secondary Outcomes (7)

• Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year

  1 Year

• Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up

  3 years

• Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years

  5 years

• Stenosis of the Parent Artery in PED at 3 Years

  3-years

• Stenosis of the Parent Artery in PED at 5 Years

  5-years

Study Arms (1)

Pipeline

EXPERIMENTAL

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

Device: Pipeline Embolization Device (PED)

Interventions

Pipeline Embolization Device (PED) DEVICE

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

Pipeline

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (10)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Rush University

Chicago, Illinois, United States

Location

Central Du Page Hospital

Winfield, Illinois, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

Washington University St. Louis

St Louis, Missouri, United States

Location

University of Buffalo

Buffalo, New York, United States

Location

New York University

New York, New York, United States

Location

Stony Brook University

Stony Brook, New York, United States

Location

National Institute of Neurosurgery

Budapest, Hungary

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27739944 DERIVED

• 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.

  PMID: 26162031 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Darren LaCour
• Organization: Medtronic

darren.j.lacour@medtronic.com

949-680-1274

Study Officials

• Tibor Bescke, MD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: October 1, 2008
• Primary Completion: September 22, 2014
• Study Completion: September 22, 2014
• Last Updated: November 20, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-10

Locations

TU (1); US (8); HU (1)