Clinical trial NCT04870047: Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
Official title: Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Phenox GmbH
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. 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.
3. 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).
4. Subject has already been selected for flow diversion therapy as the appropriate treatment.
5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
6. 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).

Exclusion Criteria:

1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
4. Subject with target aneurysm previously treated with a stent or flow diverter.
5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
6. Subject with a confirmed stenosis in parent artery.
7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
8. Subject has a pre-procedure mRS \>2.
9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
11. Known serious sensitivity to radiographic contrast agents.
12. Known sensitivity to nickel, titanium metals, or their alloys.
13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30.
15. Subject who has a contraindication to MRI or angiography for whatever reason.
16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
17. Subject with any known allergy to heparin, ASA or other antiplatelet medications.
18. Subject with coagulation disorder
19. Pregnant woman or breast feeding.
20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.

Primary outcomes:
measure: Number of DWI lesions
timeFrame: 48 hours (± 24 hours)
Secondary outcomes:
measure: Short-term morbi-mortality rate
timeFrame: 30 days (± 7 days)
measure: Rate of neurological death or major stroke
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Long-term morbi-mortality rate
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Rate of subjects with dissusion-weighted imaging (DWI) lesions
timeFrame: 48 hours (± 24 hours)
measure: Delayed aneurysm rupture
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Delayed intraparenchymal hemorrhage
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Rate of peripheral bleeding
timeFrame: Any event reported from discharge to 365 days (335 - 456 days) post procedure
measure: Rate of device deployment at the target site without technical complications
timeFrame: During intervention
measure: Rate of complete aneurysm occlusion
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Rate of target aneurysm recurrence
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Rate of target aneurysm retreatment
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Rate of intrastent stenosis and/or thrombosis at the target site
timeFrame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
measure: Mean length of hospital stay
timeFrame: From admission up to discharge, assessed up to 456 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lyon
country: France
facility: CHU de Lyon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Reims
country: France
facility: CHU Reims - Hôpital Maison Blanche
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: München
country: Germany
facility: Klinikum der LMU München
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Recklinghausen
country: Germany
facility: Klinikum Vest Recklinghausen
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
city: Milan
country: Italy
facility: Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
city: Košice
country: Slovakia
facility: UNLP Košice
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Birmingham
country: United Kingdom
facility: Queen Elisabeth Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: CHRU Hôpital Maison-Blanche
name: Laurent Pierot, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.