Intracranial AneurysmsPhase 4GELATINNCT02037932
Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
A Phase 4 study testing Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. in people with Intracranial Aneurysms and Aneurysm, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms, Aneurysm, Brain Aneurysm
- What is being tested?
- Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Patient is 18-80 years of age.
- Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
- Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
- Patient has a Hunt and Hess Score of 3 or less.
- Patient has a premorbid mRS of 3 or less.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient is willing to and can comply with study follow-up requirements.
Who cannot join
- Inability to obtain informed consent.
- Patient is <18 or >80 years of age.
- Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
- Aneurysm that was treated previously with stent-assisted coiling.
- Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
- Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.
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- Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.
- Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).
- Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).
- Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)
- Patients with a life expectancy of ≤ 9 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.
Read the detailed description
This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.
- Conditions
- Intracranial Aneurysms, Aneurysm, Brain Aneurysm
- Being tested
- Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
- Keywords
- Aneurysm, Brain Aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.Device
Also called MicroVention hydrogel coils, MicroVention Scepter C, MicroVention Scepter XC
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Assisted Coiling | Experimental | Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. Receives: Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm recurrence rate
Measured: 3-9 month follow-up
Secondary outcomes (8)
Occlusion Rate
Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.
Measured: At immediate post-procedure (Day 1) and 3-9 month follow-up
Number of coils used
Measured: At end of study procedure (Day 1)
Total coil length used
Measured: At immediate post-procedure (Day 1)
Aneurysm re-treatment rate
Measured: 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate
Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
Measured: 3-9 month follow-up
Time of fluoroscopic exposure
Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.
Measured: At immediate post-procedure (Day 1)
Modified Rankin Score
Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
Measured: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Device-related serious adverse events
Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.
Measured: From the study procedure (Day 1) until 3-9 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Investigator left institution
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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Microvention-Terumo, Inc.
- Responsible party
- Sponsor
- Investigators
- Osama O Zaidat, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037932
- Sponsor's protocol ID
- 00021229
- Acronym
- GELATIN
- Status last verified
- Nov 2015
- First submitted
- 14 Jan 2014
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
- ClinicalTrials.gov ID
- NCT02037932
- Acronym / sponsor ID
- GELATIN / 00021229
- Conditions
- Intracranial Aneurysms, Aneurysm, Brain Aneurysm
- Keywords
- Aneurysm, Brain Aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Microvention-Terumo, Inc.
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Jan 2014 (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 objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.
Detailed description
This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon Assisted Coiling | Experimental | Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is 18-80 years of age.
- Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
- Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
- Patient has a Hunt and Hess Score of 3 or less.
- Patient has a premorbid mRS of 3 or less.
Key exclusion criteria (11 listed)
- Inability to obtain informed consent.
- Patient is <18 or >80 years of age.
- Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
- Aneurysm that was treated previously with stent-assisted coiling.
- Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
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 |
|---|---|---|
| Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.Also: MicroVention hydrogel coils, MicroVention Scepter C, MicroVention Scepter XCBalloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. | Device | Balloon Assisted Coiling |
Primary outcome
Aneurysm recurrence rate
Time frame: 3-9 month follow-up
8 secondary outcomes
Occlusion Rate
Time frame: At immediate post-procedure (Day 1) and 3-9 month follow-up
Number of coils used
Time frame: At end of study procedure (Day 1)
Total coil length used
Time frame: At immediate post-procedure (Day 1)
Aneurysm re-treatment rate
Time frame: 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate
Time frame: 3-9 month follow-up
Time of fluoroscopic exposure
Time frame: At immediate post-procedure (Day 1)
Modified Rankin Score
Time frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Device-related serious adverse events
Time frame: From the study procedure (Day 1) until 3-9 month follow up
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 6 Nov 2015.
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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.
Osama O Zaidat, MD, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter. in people with Intracranial Aneurysms and Aneurysm, run by Medical College of Wisconsin at 1 site in United States.
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 11 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 6 Nov 2015. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Aneurysm recurrence rate (time frame: 3-9 month follow-up). 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 6 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.