CompletedNot Applicable

Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

Argentina, Belgium, Bulgaria450 participantsStarted 2015-12

Plain-language summary

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18
✓. Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
✓. Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)

✕. Aneurysms of the posterior circulation
✕. Imaging evidence of bifurcation aneurysms
✕. Imaging evidence of dissections
✕. Imaging evidence of fistulae
✕. Imaging evidence of arteriovenous malformations
✕. Patient is harbouring another aneurysm that has to be treated within six months after first procedure
✕. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
✕. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

Change in the rate of complete occlusion

Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months

Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm

Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months

NCT IDNCT02600364

SponsorPhenox GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-06

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18
✓. Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
✓. Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)

✕. Aneurysms of the posterior circulation
✕. Imaging evidence of bifurcation aneurysms
✕. Imaging evidence of dissections
✕. Imaging evidence of fistulae
✕. Imaging evidence of arteriovenous malformations
✕. Patient is harbouring another aneurysm that has to be treated within six months after first procedure
✕. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
✕. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

What they're measuring

Change in the rate of complete occlusion

Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months

Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm

Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months