Intracerebral HemorrhagePRONTONCT04178746
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
An observational study of Intracerebral Hemorrhage and Brain Hemorrhage, run by Penumbra Inc. at 1 site in United States.
Trial summary
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage
- What is being tested?
- Artemis Neuro Evacuation Device
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 2 Jun 2021
- How long will I take part?
- 30 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spontaneous Intraventricular Hemorrhage not related to underlying vascular abnormality.
Who may be able to join
- ≥ 18 years in age
- Patients presenting with Intraventricular Hemorrhage (IVH) qualifying for hematoma evacuation
- Controlled SBP ≤ 180 mmHg after initial NCCT scan and prior to the initiation of the MIS procedure
- Hyper-acute phase, as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scan and no longer than 18 hours since time patient last known well
- Symptomatic with radiographic evidence of cerebral compression edema
- Pre-stroke mRS 0 - 2
Who cannot join
- Presence of tentorial herniation and/or Kernohan's phenomenon
- Uncontrolled ICP as defined as > 25 mmHg for more than 30 min for 3 consecutive hours after External Ventricular Drain (EVD) placement
- Requirement of insulin drip
- Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
- Unable to obtain consent from patient or legally authorized representative (LAR) (for patients without competence)
- Presenting epilepticus that is not controlled
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- Nonreversible coagulopathy (INR > 1.4) or platelet deficiency (< 75 x 103 cells/mm3) not able to be corrected with currently accepted treatment medications
- Contraindication to conventional angiography, CTA, and MRA
- Life expectancy of < 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Neuroscience Institute
Summit, New Jersey, 07901
About this study
Official title: PRONTO: Minimally Invasive Endoscopic Surgery Utilizing the Artemis Neuro Evacuation Device in Patients With Intraventricular Hemorrhage in the Hyper-Acute Phase
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
Read the detailed description
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
The enrollment period will end once 20 evaluable subjects have been enrolled in the registry. Each subject will be in the registry for approximately 1 month.
- Being tested
- Artemis Neuro Evacuation Device
- Keywords
- intraventricular hemorrhage, IVH, stroke
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemis Neuro Evacuation DeviceDevice
The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
The Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope.
| Study group | Role | What they receive |
|---|---|---|
| IVH subjects in the Hyper-Acute Phase | The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in approximately 20 subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. For the purposes of this registry, the hyper-acute phase as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scans and no longer than 18 hours since time patients last known well. Receives: Device: Artemis Neuro Evacuation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Measured: 24 hours
Safety Endpoint: Rate of mortality at 30 days
Rate of mortality at 30 days
Measured: 30 days
Secondary outcomes (3)
Time of admission at treating facility to discharge (Length of stay)
Measured: admission to discharge, a period of up to 30 days
Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure
Measured: 30 days
Procedure and device related SAEs
Measured: time of surgery up to 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start26 Sep 2019
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Why it stopped: Business decision to focus on other studies. No safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Saphier, MD, Principal investigator, Atlantic Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178746
- Sponsor's protocol ID
- 14087
- Acronym
- PRONTO
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2019
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRONTO: Minimally Invasive Endoscopic Surgery Utilizing the Artemis Neuro Evacuation Device in Patients With Intraventricular Hemorrhage in the Hyper-Acute Phase
- ClinicalTrials.gov ID
- NCT04178746
- Acronym / sponsor ID
- PRONTO / 14087
- Keywords
- intraventricular hemorrhage, IVH, stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision to focus on other studies. No safety concern.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 26 Nov 2019 (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 prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
Detailed description
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
The enrollment period will end once 20 evaluable subjects have been enrolled in the registry. Each subject will be in the registry for approximately 1 month.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVH subjects in the Hyper-Acute Phase | – | Device: Artemis Neuro Evacuation DeviceThe purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in approximately 20 subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. For the purposes of this registry, the hyper-acute phase as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scans and no longer than 18 hours since time patients last known well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spontaneous Intraventricular Hemorrhage not related to underlying vascular abnormality.
Key inclusion criteria (6 listed)
- ≥ 18 years in age
- Patients presenting with Intraventricular Hemorrhage (IVH) qualifying for hematoma evacuation
- Controlled SBP ≤ 180 mmHg after initial NCCT scan and prior to the initiation of the MIS procedure
- Hyper-acute phase, as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scan and no longer than 18 hours since time patient last known well
- Symptomatic with radiographic evidence of cerebral compression edema
Key exclusion criteria (9 listed)
- Presence of tentorial herniation and/or Kernohan's phenomenon
- Uncontrolled ICP as defined as > 25 mmHg for more than 30 min for 3 consecutive hours after External Ventricular Drain (EVD) placement
- Requirement of insulin drip
- Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
- Unable to obtain consent from patient or legally authorized representative (LAR) (for patients without competence)
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 |
|---|---|---|
| Artemis Neuro Evacuation DeviceThe Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope. | Device | IVH subjects in the Hyper-Acute Phase |
Primary outcome
Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Time frame: 24 hours
Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Safety Endpoint: Rate of mortality at 30 days
Time frame: 30 days
Rate of mortality at 30 days
3 secondary outcomes
Time of admission at treating facility to discharge (Length of stay)
Time frame: admission to discharge, a period of up to 30 days
Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure
Time frame: 30 days
Procedure and device related SAEs
Time frame: time of surgery up to 30-day follow-up
Results and safety
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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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.
Paul Saphier, MD principal investigator
Atlantic Neuroscience Institute
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 Intracerebral Hemorrhage and Brain Hemorrhage, run by Penumbra Inc. 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 6 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: stopped early, as of the sponsor's last update on 14 Sep 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 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.
Are results available for this study?
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern.). 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?
Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours (time frame: 24 hours). 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 14 Sep 2022.