Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

NCT04870047 | Active Not Recruiting DMC

• 1 other identifier: CO48/BO1309
• Study Type: interventional
• Target: 171
• Locations: 7 countries
• Sites: 18

Brief Summary

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Number of DWI lesions

  Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.

  48 hours (± 24 hours)

Secondary Outcomes (13)

• Short-term morbi-mortality rate

  30 days (± 7 days)

• Rate of neurological death or major stroke

  180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

• Long-term morbi-mortality rate

  180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

• Rate of subjects with dissusion-weighted imaging (DWI) lesions

  48 hours (± 24 hours)

• Delayed aneurysm rupture

  180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Study Arms (2)

p64 MW HPC Flow Diverter + SAPT

EXPERIMENTAL

Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

p64 MW Flow Diverter + DAPT

EXPERIMENTAL

Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

Interventions

Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device DEVICE

Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

p64 MW Flow Diverter + DAPT; p64 MW HPC Flow Diverter + SAPT

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age.
• Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
• Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
• Subject has already been selected for flow diversion therapy as the appropriate treatment.
• Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
• Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).

You may not qualify if:

• Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
• Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
• Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
• Subject with target aneurysm previously treated with a stent or flow diverter.
• Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
• Subject with a confirmed stenosis in parent artery.
• Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
• Subject has a pre-procedure mRS \>2.
• Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
• Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
• Known serious sensitivity to radiographic contrast agents.
• Known sensitivity to nickel, titanium metals, or their alloys.
• Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
• Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30.
• Subject who has a contraindication to MRI or angiography for whatever reason.

Sponsors & Collaborators

• Phenox GmbH: lead

Study Sites (18)

CHU Bordeaux

Bordeaux, 33076, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU de Lyon

Lyon, 69002, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

CHU Reims - Hôpital Maison Blanche

Reims, 51092, France

Location

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Klinikum der LMU München

München, 81377, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Klinikum Vest Recklinghausen

Recklinghausen, Germany

Location

Klinikum Stuttgart

Stuttgart, 70174, Germany

Location

Hadassah University Medical Center

Jerusalem, 9112001, Israel

Location

Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

UNLP Košice

Košice, 04190, Slovakia

Location

Universitätsspital Basel

Basel, 4051, Switzerland

Location

Queen Elisabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Related Publications (2)

• Ramirez-Velandia F, Enriquez-Marulanda A, Filo J, Young M, Fodor TB, Sconzo D, Muram S, Granstein JH, Shutran M, Taussky P, Ogilvy CS. Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis. Neurosurgery. 2024 Aug 1;95(2):330-338. doi: 10.1227/neu.0000000000002883. Epub 2024 Feb 23.

  PMID: 38391195 DERIVED

• Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspotter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24.

  PMID: 35609974 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

Study Officials

• Laurent Pierot, Prof. Dr.

  CHRU Hôpital Maison-Blanche

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: September 3, 2021
• Primary Completion: December 4, 2024
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); DE (7); FR (5); IT (1); SL (1); CH (1); IL (1)