An observational study in Intracranial Aneurysm, Aneurysm and Vascular Diseases, sponsored by Phenox GmbH. Status unknown at 1 site in Mongolia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Phenox GmbH · Observational
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.
Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication.
Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication in consecutive patients with unruptured anterior circulation aneurysms.
Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 90 is below the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Phenox GmbH is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target population for this Observational Registry are patients with unruptured intracranial aneurysms suitable for flow diversion on operators' discretion. Patients can be included in the Observational Registry if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endovascular treatment of intracranial aneurysms with flow diversion.
Safety endpoint
Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.
Time frame: Within 30 days after the intervention
Safety endpoint
Occurence of all adverse events and serious adverse events, related directly or indirectly to the intervention, the used device or the required medication.
Time frame: Within the first 12 months after the intervention
Efficacy endpoint
Complete occlusion or the neck remnant of the target aneurysm(s), identified by DSA (Digital subtraction angiography).
Time frame: 12 months after the intervention
Plan to share: No
Started Jun 2019 (actual). Primary completion is estimated for Jun 2023, 48 months after the start.
Of 104 observational studies under Intracranial Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 145. This study's planned 48 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Phenox GmbH