Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Intracranial Aneurysm Clinical Trial

— COATING  

Official title:

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870047
• Other study ID #: CO48/BO1309
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Phenox GmbH
• Contact: Elisabeth Demant-Bauchspiess
• Phone: +49 (0)173 3099117
• Email: COATING[@]wallabyphenox.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CHU de Lyon	Lyon
France	Marseille University Hospital Timone	Marseille
France	CHU de Montpellier	Montpellier
France	CHU Reims - Hôpital Maison Blanche	Reims
France	CHU Toulouse	Toulouse
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Universitätsklinikum Halle (Saale)	Halle
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Klinikum der LMU München	München
Germany	Klinikum Nürnberg Süd	Nürnberg
Germany	Klinikum Vest Recklinghausen	Recklinghausen
Germany	Klinikum Stuttgart	Stuttgart
Israel	Hadassah University Medical Center	Jerusalem
Italy	Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta	Milan
Slovakia	UNLP Košice	Košice
Switzerland	Universitätsspital Basel	Basel
United Kingdom	Queen Elisabeth Hospital Birmingham	Birmingham
United Kingdom	Western General Hospital	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Phenox GmbH

Countries where clinical trial is conducted

France,  Germany,  Israel,  Italy,  Slovakia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short-term morbi-mortality rate	Morbi-mortality rate at 30 days assessed by mRS > 2	30 days (± 7 days)
Secondary	Rate of neurological death or major stroke	Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Long-term morbi-mortality rate	Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Rate of subjects with dissusion-weighted imaging (DWI) lesions	Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke	48 hours (± 24 hours)
Secondary	Delayed aneurysm rupture	Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Delayed intraparenchymal hemorrhage	Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Rate of peripheral bleeding	Rate of peripheral bleeding, as assessed by the Clinical Events Committee	Any event reported from discharge to 365 days (335 - 456 days) post procedure
Secondary	Rate of device deployment at the target site without technical complications	Rate of device deployment at the target site without technical complications, as assessed by the site	During intervention
Secondary	Rate of complete aneurysm occlusion	Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Rate of target aneurysm recurrence	Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Rate of target aneurysm retreatment	Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Rate of intrastent stenosis and/or thrombosis at the target site	Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Secondary	Mean length of hospital stay	Mean length of hospital stay (from hospital admission and up to hospital discharge)	From admission up to discharge, assessed up to 456 days