Chronic Subdural Hematoma(COAST)NCT07715656
Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas
A study testing embolization therapy Bilateral and embolization therapy Unilateral in people with Chronic Subdural Hematoma, run by Lahey Clinic at 1 site in United States.
Trial summary
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- embolization therapy Bilateral and embolization therapy Unilateral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Candidates for this study must meet ALL of the following criteria:
- Subject is 18 years of age or older.
- Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
- Pre-randomization modified Rankin Score (mRS) ≤3
- Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.
- Subdural Hematoma Size
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- Medical Management Cohort:
- Midline shift < 10mm and hematoma thickness > 10 mm as measured on coronal imaging perpendicular to the skull.
- No focal deficit related to the chronic subdural hematoma requiring surgical intervention
- Surgical Cohort:
- No requirement
- A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
- Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
- In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.
Who cannot join
- Candidates will be excluded from participation if ANY of the following apply:
- Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.
- Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH <5mm and not requiring treatment is permitted.
- Subject presents with Glasgow Coma Scale < 9
- Markwalder assessment >4
- cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy
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- Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma
- Presumed septic embolus, or suspicion of microbial superinfection
- CT or MRI evidence of intra-cranial tumor or mass lesion
- Significant contraindication to angiography (eg. kidney failure).
- Life expectancy of less than 1-year
- Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans
- Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803
Kimberly Silverman, 7817443330, Kimberly.Silverman@lahey.org
About this study
Official title: Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
Read the detailed description
This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- embolization therapy Bilateral, embolization therapy Unilateral
- Keywords
- cSDH, Chronic subdural hematoma, Coils, Embolization, eMMA
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization therapy BilateralDevice
In the bilateral approach, both middle meningeal arteries are accessed and embolized using coils, regardless of hematoma location. Imaging guidance is used throughout the procedure to ensure proper coil placement, and post-procedure imaging confirms that both vessels are fully occluded.
embolization therapy UnilateralDevice
In the unilateral approach, the middle meningeal artery (MMA) on the side of the hematoma is accessed via a catheter and occluded using coils under imaging guidance. The procedure targets only the affected side, and follow-up imaging is used to confirm successful embolization and vessel occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | Active comparator | In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils as part of their medical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location. Receives: Device: embolization therapy Bilateral; Device: embolization therapy Unilateral |
| Surgical | Active comparator | In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils in addition to standard surgical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location. Receives: Device: embolization therapy Bilateral; Device: embolization therapy Unilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT
Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.
Measured: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)
Secondary outcomes (3)
Number of Participants Requiring Additional surgical Intervention
Number of participants requiring additional surgical treatment after randomization, including initial surgical evacuation in the medical management cohort or repeat hematoma evacuation in the surgical cohort.
Measured: Through 3 months
Change from Baseline in Modified Rankin scale (mRS) Score
Functional outcome measured using the Modified Rankin Scale (range 0-6). change from baseline will be reported.
Measured: Baseline, 1 month, and 3 months
Number of participants with Procedure-related Serious Adverse Events
Number of participants experiencing procedure related adverse events, including but not limited to ischemic stroke, intracranial hemorrhage, arterial dissection, vessel perforation, access-site complications requiring intervention, or death.
Measured: through 3 months after embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start9 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Pace, Lahey Clinic
- Investigators
- Jonathan Pace, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715656
- Sponsor's protocol ID
- 20253018
- Acronym
- (COAST)
- Status last verified
- Mar 2026
- First submitted
- 22 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07715656
- Acronym / sponsor ID
- (COAST) / 20253018
- Conditions
- Chronic Subdural Hematoma
- Keywords
- cSDH, Chronic subdural hematoma, Coils, Embolization, eMMA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jul 2026 (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.
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
Detailed description
This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Management | Active comparator | Device: embolization therapy Bilateral, Device: embolization therapy UnilateralIn this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils as part of their medical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location. |
| Surgical | Active comparator | Device: embolization therapy Bilateral, Device: embolization therapy UnilateralIn this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils in addition to standard surgical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is 18 years of age or older.
- Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
- Pre-randomization modified Rankin Score (mRS) ≤3
- Subdural Hematoma Size
- A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
Key exclusion criteria (14 listed)
- Candidates will be excluded from participation if ANY of the following apply:
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 |
|---|---|---|
| embolization therapy BilateralIn the bilateral approach, both middle meningeal arteries are accessed and embolized using coils, regardless of hematoma location. Imaging guidance is used throughout the procedure to ensure proper coil placement, and post-procedure imaging confirms that both vessels are fully occluded. | Device | Medical Management, Surgical |
| embolization therapy UnilateralIn the unilateral approach, the middle meningeal artery (MMA) on the side of the hematoma is accessed via a catheter and occluded using coils under imaging guidance. The procedure targets only the affected side, and follow-up imaging is used to confirm successful embolization and vessel occlusion. | Device | Medical Management, Surgical |
Primary outcome
Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT
Time frame: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)
Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.
3 secondary outcomes
Number of Participants Requiring Additional surgical Intervention
Time frame: Through 3 months
Change from Baseline in Modified Rankin scale (mRS) Score
Time frame: Baseline, 1 month, and 3 months
Number of participants with Procedure-related Serious Adverse Events
Time frame: through 3 months after embolization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Pace, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolization therapy Bilateral and embolization therapy Unilateral in people with Chronic Subdural Hematoma, run by Lahey Clinic 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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy L Alvarez, MD (7865800186, sandy.l.alvarez@lahey.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT (time frame: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)). 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 20 Jul 2026.