Intracranial AneurysmsNCT01945827
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
An observational study of Intracranial Aneurysms, run by Codman & Shurtleff.
Trial summary
The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- DeltaMaxx Microcoil System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- How long will I take part?
- 12 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: Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.
Who may be able to join
- Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
- Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
- Investigator intends to use only Codman Neuro microcoils during coiling procedure
- Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen] ≥6 mm
- If ruptured aneurysm: Hunt and Hess 1, 2, or 3
- If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
- The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.
Who cannot join
- Prior treatment (surgical or endovascular) of the target aneurysm
- Subjects with more than one aneurysm (>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
- Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
- Women who are pregnant or plan to become pregnant during the study
- Life expectancy less than 12 months.
- Presence of arteriovenous malformation
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- Fusiform, mycotic, traumatic, or tumoral aneurysms
- Planned aneurysm treatment by parent vessel occlusion
- Subject enrolled in any concurrent study
About this study
The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
- Conditions
- Intracranial Aneurysms
- Being tested
- DeltaMaxx Microcoil System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeltaMaxx Microcoil SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| DeltaMaxx treated Patients | Not described Receives: Device: DeltaMaxx Microcoil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Objective - Angiographic Outcomes
The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale
Measured: 12 Months
Primary Safety Endpoint - Neurological Morbidity and Mortality
Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study
Measured: 12 months
Secondary outcomes (3)
Packing Density
Packing density as measured by volumetric filling of the aneurysm post-procedure after the coils have been placed as indicated by angiographic films taken at the end of the coiling procedure
Measured: 24 hours
Recurrence Rate
Measured: 12 months
Re-treatment Rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945827
- Sponsor's protocol ID
- CD-000036-PRO
- Status last verified
- Jul 2014
- First submitted
- 12 Sep 2013
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01945827
- Acronym / sponsor ID
- CD-000036-PRO
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- 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 primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DeltaMaxx treated Patients | – | Device: DeltaMaxx Microcoil System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.
Key inclusion criteria (7 listed)
- Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
- Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
- Investigator intends to use only Codman Neuro microcoils during coiling procedure
- Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen] ≥6 mm
- If ruptured aneurysm: Hunt and Hess 1, 2, or 3
Key exclusion criteria (9 listed)
- Prior treatment (surgical or endovascular) of the target aneurysm
- Subjects with more than one aneurysm (>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
- Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
- Women who are pregnant or plan to become pregnant during the study
- Life expectancy less than 12 months.
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 |
|---|---|---|
| DeltaMaxx Microcoil System | Device | DeltaMaxx treated Patients |
Primary outcome
Primary Effectiveness Objective - Angiographic Outcomes
Time frame: 12 Months
The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale
Primary Safety Endpoint - Neurological Morbidity and Mortality
Time frame: 12 months
Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study
3 secondary outcomes
Packing Density
Time frame: 24 hours
Recurrence Rate
Time frame: 12 months
Re-treatment Rate
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Codman & Shurtleff.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Objective - Angiographic Outcomes (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 3 Jul 2014.