Pipeline for Uncoilable or Failed Aneurysms

Intracranial Aneurysm Clinical Trial

— PUFS  

Official title:

Pipeline for Uncoilable or Failed Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777088
• Other study ID #: COVPUFS0398
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: September 22, 2014

Study information

• Verified date: October 2018
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 22, 2014
• Est. primary completion date: September 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Locations

Country	Name	City	State
Hungary	National Institute of Neurosurgery	Budapest
Turkey	Hacettepe University	Ankara
United States	University of Buffalo	Buffalo	New York
United States	Rush University	Chicago	Illinois
United States	New York University	New York	New York
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University St. Louis	Saint Louis	Missouri
United States	Stony Brook University	Stony Brook	New York
United States	Central Du Page Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Countries where clinical trial is conducted

United States,  Hungary,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year	The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. 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	1 Year
Secondary	Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up	The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. 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	3 years
Secondary	Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years	The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. 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	5 years
Secondary	Stenosis of the Parent Artery in PED at 3 Years	Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up	3-years
Secondary	Stenosis of the Parent Artery in PED at 5 Years	Parent artery stenosis at 5-year follow-up	5-years
Secondary	Number of Participants With Device-Related Adverse Events at 3 Years	Number of participants with incidence of device-related adverse events at 3 year follow-up	3 years
Secondary	Number of Participants With Device-related Adverse Events at 5 Years	Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement	5 years