Intracranial AneurysmCOMATS 1NCT04305626
Coated Mongolian Aneurysm Treatment Study 1
An observational study of Intracranial Aneurysm and Aneurysm, run by Phenox GmbH at 1 site in Mongolia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- What is being tested?
- Endovascular treatment of intracranial aneurysms
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteMongolia
- Study dates
- 22 Jun 2019to 30 Dec 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- At least one unruptured sidewall aneurysm in the anterior circulation
- No implant (e.g., stent) in the target vessel segment
- Age >18 years and <80 years
- Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
- No participation in another trial
- No concomitant disease limiting the life expectancy to <2 years
Show all 10Show fewer
- No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists
- No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future
- Ability and willingness to comply with the medication requirements within the study,
- Ability to understand the goal and risks of this study.
Who cannot join
- Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
- Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
- Another intracranial procedure scheduled for the following 6 months.
- Age < 18 years and > 80 years.
- Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
- Patient not able or willing to adhere to the study protocol.
- Patient not able or willing to undergo the scheduled follow-up examinations.
Trial locations and contacts
1 site in 1 country.
Andrey Petrov, Dr. contact
Mongolia1 site, 1 recruiting
- Recruiting
Shastin Central Hospital
Ulaanbaatar, Bayangol District, 10th khoroolol-2
Ganbaatar Rentsenkhuu, Dr., ganbaatar.neuro@gmail.com
Ganbaatar Rentsenkhuu, Dr
About this study
Official title: Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry
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.
Read the detailed description
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.
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Being tested
- Endovascular treatment of intracranial aneurysms
- Keywords
- p64 MW HPC, p48 MW HPC, Flow Diverter, HPC, Dual antiplatelet therapy, Outcome, Occlusion, Stroke
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Vascular Diseases, Bites and Stings, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of intracranial aneurysmsDevice
Endovascular treatment of intracranial aneurysms with flow diversion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.
Measured: Within 30 days after the intervention
Secondary outcomes (1)
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.
Measured: Within the first 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start22 Jun 2019
- Primary completion22 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Phenox GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305626
- Sponsor's protocol ID
- STUD-192206
- Acronym
- COMATS 1
- Status last verified
- Oct 2021
- First submitted
- 9 Mar 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry
- ClinicalTrials.gov ID
- NCT04305626
- Acronym / sponsor ID
- COMATS 1 / STUD-192206
- Conditions
- Intracranial Aneurysm, Aneurysm, Vascular Diseases
- Keywords
- p64 MW HPC, p48 MW HPC, Flow Diverter, HPC, Dual antiplatelet therapy, Outcome, Occlusion, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Phenox GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2019 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- At least one unruptured sidewall aneurysm in the anterior circulation
- No implant (e.g., stent) in the target vessel segment
- Age >18 years and <80 years
- Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
- No participation in another trial
Key exclusion criteria (7 listed)
- Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
- Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
- Another intracranial procedure scheduled for the following 6 months.
- Age < 18 years and > 80 years.
- Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment of intracranial aneurysmsEndovascular treatment of intracranial aneurysms with flow diversion. | Device | – |
Primary outcome
Safety endpoint
Time frame: Within 30 days after the intervention
Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.
1 secondary outcome
Safety endpoint
Time frame: Within the first 12 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Petrov, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Aneurysm, run by Phenox GmbH at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Henkes, Prof. Dr. (+49 711 27834501, h.henkes@klinikum-stuttgart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint (time frame: Within 30 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.