Intracerebral AneursymPhase 4HCATNCT01195129
HydroCoil Cerebral Aneurysm Treatment Trial
A Phase 4 study testing MicroVention Hydrogel coil and Non-hydrogel coils in people with Intracerebral Aneursym, run by University of Virginia at 11 sites in United States.
Trial summary
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Intracerebral Aneursym
- What is being tested?
- MicroVention Hydrogel coil and Non-hydrogel coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2008to Jun 2015
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
- The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
- Patients between (and including) 21 and 90 years of age.
- Patient HUNT AND HESS Grade 0-3.
- Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
- Aneurysm 5-20mm in maximum diameter.
Show all 9Show fewer
- Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
- The patient has not been previously randomized into this or another related ongoing trial.
- The aneurysm has not previously been treated (by coiling or clipping).
Who cannot join
- Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
- Target aneurysm has had previous coil treatment or surgically clipped.
- Patient has an H\&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
- Inability to obtain informed consent.
- Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
- -
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Mercy Stroke Center
Carmichael, California
Medical college of South Carolina
Charleston, South Carolina
University of Virginia
Charlottesville, Virginia, 22908
University of Texas Southwest Medical Center
Dallas, Texas
University of Florida
Gainesville, Florida
The Methodist Research Institute
Houston, Texas
University of Southern California
Los Angeles, California
St. Luke's/Roosevelt Hospital Center
New York, New York
Sentara Norfolk General Hospital
Norfolk, Virginia
Oregon Health and Science University
Portland, Oregon
Saint Louis University
St Louis, Missouri
About this study
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
Read the detailed description
With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.
- Conditions
- Intracerebral Aneursym
- Being tested
- MicroVention Hydrogel coil, Non-hydrogel coils
- Keywords
- Stent, cerebral aneursym, neurology, radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroVention Hydrogel coilDevice
Micro Vention Hydrogel Coils
Non-hydrogel coilsDevice
Cerecyte or bare platinum coils
| Study group | Role | What they receive |
|---|---|---|
| MicroVention Hydrogel Coils | Other | FDA approved and in common use for cerebral aneurysm treatment. Receives: Device: MicroVention Hydrogel coil |
| Non-hydrogel coils | Active comparator | Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm). Receives: Device: Non-hydrogel coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion rate
Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment.
Measured: 12 - 18 months
Secondary outcomes (7)
Treatment related morbidity and mortality
Treatment related morbidity and mortality, as measured by the NIH stroke scale;
Measured: 12-18 months
Packing density
Packing density as measured by volumetric filling of the aneurysm.
Measured: 12-18 months
Clinical outcome
Clinical outcome as measured by Modified Rankin Scale
Measured: 6 months
Clinical Outcome
Clinical outcome as measured by the Modified Rankin scale
Measured: 12-18 months
Re-bleed rates
Comparison of rebleed rates at 12-18 months
Measured: 12-18 months
Re-treatment rates
Comparison of re-treatment rates at 12-18 months post treatment.
Measured: 12-18 months
Cost of treatment
Comparison of cost of treatment.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startDec 2008
- Primary completionApr 2013
- Study completionJun 2015 (estimated)
Why it stopped: Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral AneursymStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Microvention-Terumo, Inc.
- Responsible party
- Sponsor
- Investigators
- Avery J Evans, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195129
- Sponsor's protocol ID
- 13861
- Acronym
- HCAT
- Status last verified
- Dec 2014
- First submitted
- 2 Sep 2010
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HydroCoil Cerebral Aneurysm Treatment Trial
- ClinicalTrials.gov ID
- NCT01195129
- Acronym / sponsor ID
- HCAT / 13861
- Conditions
- Intracerebral Aneursym
- Keywords
- Stent, cerebral aneursym, neurology, radiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Microvention-Terumo, Inc.
- Study start
- Dec 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 3 Sep 2010 (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 study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
Detailed description
With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroVention Hydrogel Coils | Other | Device: MicroVention Hydrogel coilFDA approved and in common use for cerebral aneurysm treatment. |
| Non-hydrogel coils | Active comparator | Device: Non-hydrogel coilsCerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm). |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
- The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
- Patients between (and including) 21 and 90 years of age.
- Patient HUNT AND HESS Grade 0-3.
- Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
Key exclusion criteria (6 listed)
- Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
- Target aneurysm has had previous coil treatment or surgically clipped.
- Patient has an H\&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
- Inability to obtain informed consent.
- Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
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 |
|---|---|---|
| MicroVention Hydrogel coilMicro Vention Hydrogel Coils | Device | MicroVention Hydrogel Coils |
| Non-hydrogel coilsCerecyte or bare platinum coils | Device | Non-hydrogel coils |
Primary outcome
Occlusion rate
Time frame: 12 - 18 months
Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment.
7 secondary outcomes
Treatment related morbidity and mortality
Time frame: 12-18 months
Packing density
Time frame: 12-18 months
Clinical outcome
Time frame: 6 months
Clinical Outcome
Time frame: 12-18 months
Re-bleed rates
Time frame: 12-18 months
Re-treatment rates
Time frame: 12-18 months
Cost of treatment
Time frame: 12-18 months
Results and safety
The study was stopped early (reason given: Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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.
Avery J Evans, MD principal investigator
University of Virginia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MicroVention Hydrogel coil and Non-hydrogel coils in people with Intracerebral Aneursym, run by University of Virginia at 11 sites 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 stopped early (reason given: Due to results shown by the Cerecyte Clinical Trial, HCAT stopped enrolling.). Results are not available in the source record.
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?
Occlusion rate (time frame: 12 - 18 months). 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 12 Dec 2014.