Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

NCT02186561 | Completed Results DMC FDA Device

• 1 other identifier: NV-PED-07
• Study Type: interventional
• Target: 197
• Locations: 2 countries
• Sites: 23

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Conditions

Intracranial Aneurysm

Keywords

Intracranial aneurysm; brain aneurysm

Outcome Measures

Primary Outcomes (2)

• The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure

  The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

  Up to 12 Months Post Procedure

• The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure

  The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

  Up to 12 Months Post Procedure

Secondary Outcomes (3)

• The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications

  Up to 30 days, Post Procedure

• The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure

  > 30 days, Post Procedure

• The Number of Participants With Successfully Deployed Investigational Device

  Index Procedure

Study Arms (1)

Pipeline™ Embolization Device

EXPERIMENTAL

treatment with Pipeline™ Embolization Device

Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device

Interventions

Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device DEVICE

Pipeline™ Embolization Device

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
• Age 22-80 years.
• Subject has a target intracranial aneurysm (IA) located in the:
• Internal carotid artery (up to the carotid terminus) OR
• Vertebral artery segment up to and including the posterior inferior cerebellar artery
• Subject has a target IA that is ≤ 12 mm.
• Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
• Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
• Subject has a pre-procedure PRU value between 60-200.

You may not qualify if:

• Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
• Subarachnoid hemorrhage in the past 30 days.
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
• Major surgery in the last 30 days.
• History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
• Any known contraindication to treatment with the Pipeline™ device, including:
• Stent is in place in the parent artery at the target IA location
• Contraindication to dual antiplatelet therapy
• Relative contraindication to angiography (e.g., serum creatinine \>2.5 mg/dL, allergy to contrast that cannot be medically controlled).
• Known severe allergy to platinum or cobalt/chromium alloys.
• Evidence of active infection at the time of treatment (e.g., fever with temperature \>38°C and/or WBC \>1.5 109/L).
• The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
• Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
• Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (23)

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Florida Hospital

Winter Park, Florida, 32789, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Baptist Physicians Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts University Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Kaleida Health/University of Buffalo

Buffalo, New York, 14203, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

St. Luke's Health Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (3)

• Rodriguez-Erazu F, Cortez GM, Lopes DK, Gutierrez-Aguirre SF, De Toledo OF, Aghaebrahim A, Sauvageau E, Kallmes DF, Fiehler J, Hanel RA. Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data. J Neurointerv Surg. 2025 Nov 18;17(12):1362-1367. doi: 10.1136/jnis-2024-022350.

  PMID: 39357888 DERIVED

• Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.

  PMID: 35292570 DERIVED

• Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15.

  PMID: 31308197 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: Senior Project Manager, Clinical Project Management
• Organization: Medtronic Neurovascular, Clinical Affairs

darren.j.lacour@medtronic.com

949-680-1274

Study Officials

• Ricardo Hanel, M.D.

  Baptist Medical Center

  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: July 8, 2014
• First Posted: July 10, 2014
• Study Start: July 24, 2014
• Primary Completion: November 18, 2016
• Study Completion: December 13, 2018
• Last Updated: December 27, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (22)