Cerebral AneurysmsNOVANCT07246148
NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization
A study testing Non-invasive continuous blood pressure monitoring and Invasive arterial blood pressure monitoring in people with Cerebral Aneurysms and Intracranial Aneurysms, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cerebral Aneurysms, Intracranial Aneurysms, Coil Embolization
- What is being tested?
- Non-invasive continuous blood pressure monitoring and Invasive arterial blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2026to 31 Aug 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥19 and ≤80 years old) scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
Who cannot join
- Patients who do not provide informed consent.
- Patients unable to understand or follow study instructions due to physical or mental limitations.
- Patients in whom radial arterial catheterization is not feasible (e.g., peripheral vascular disease, skin disorders at the insertion site, absence of radial/ulnar artery, or orthopedic conditions of the upper extremity).
- Patients with peripheral vascular circulatory disorders.
- Patients with morbid obesity (BMI ≥ 40 kg/m²) [Eley et al., 2021].
- Patients who are hemodynamically unstable preoperatively or expected to be unstable during the perioperative period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Eunji Ko, M.D., Ph.D., +82-2-920-5632, froken.ko@gmail.com
About this study
Official title: A Randomized Controlled Trial on Non-Invasive Continuous Blood Pressure Monitoring as an Alternative to Radial Arterial Catheterization in Patients Undergoing Coil Embolization for Intracranial Aneurysms
The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms.
The main questions it aims to answer are:
Read more
- Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP?
- Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes?
Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring.
Participants will:
- Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization.
- Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂).
- Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols.
- Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.
Read the detailed description
Intracranial aneurysm coil embolization is a widely accepted treatment for unruptured aneurysms, but the procedure is frequently accompanied by hemodynamic instability, particularly episodes of hypotension and hypertension, which may increase the risk of neurological or cardiovascular complications. Continuous and reliable arterial blood pressure monitoring is therefore critical during the periprocedural period.
The conventional standard of care has been invasive arterial blood pressure (IABP) monitoring using a radial arterial catheter. Although IABP provides accurate real-time hemodynamic data, it is associated with procedural risks such as bleeding, hematoma, arterial occlusion, distal ischemia, infection, and patient discomfort. These risks are particularly relevant in patients undergoing neuroendovascular procedures where vascular access and anticoagulation may already increase complication risk.
The ClearSight™ system (Edwards Lifesciences, Irvine, CA, USA) is a non-invasive continuous blood pressure monitoring device that uses a finger cuff based on the volume clamp method and pulse contour analysis. Previous studies have validated its use in a variety of surgical and perioperative settings, including obese patients, vascular surgery, and cardiac surgery [Kim et al., 2014; Maheshwari et al., 2018; Bugarini et al., 2021; Chapalain et al., 2024]. However, its role as a primary monitoring modality during neuroendovascular procedures has not been fully established.
This randomized controlled trial (NOVA study) is designed to determine whether non-invasive continuous blood pressure monitoring (NVBP) can serve as a safe and effective alternative to radial IABP in patients undergoing coil embolization for unruptured intracranial aneurysms. Patients will be randomized in a 1:1 ratio to receive either NVBP monitoring (experimental arm) or standard IABP monitoring (control arm). All participants will also undergo cerebral oxygenation monitoring with O₃® Regional Oximetry (Masimo, CA, USA) to detect potential cerebral desaturation events.
In the NVBP group, invasive arterial pressure will not be obtained from a radial catheter but may be secondarily recorded from a femoral arterial catheter used for the endovascular procedure itself. Importantly, the femoral arterial waveform will not be displayed to the anesthesiologist but will be recorded by nursing staff to ensure patient safety and allow for event adjudication if NVBP and IABP values diverge significantly.
The primary endpoint of this study is the intraoperative incidence of hemodynamic events, defined as episodes of hypotension (mean arterial pressure <65 mmHg sustained for ≥1 minute) or hypertension (systolic blood pressure >120 mmHg sustained for ≥1 minute). Secondary endpoints include vasopressor and antihypertensive drug use (type, dose, frequency), incidence of cerebral desaturation events (≥20% reduction from baseline or absolute rSO₂ <50), ICU admission and length of stay, overall hospital length of stay, 30-day mortality, reoperation rate, and incidence of major postoperative complications (neurologic, cardiovascular, or acute kidney injury).
To minimize performance bias, intraoperative management will follow a standardized anesthetic protocol including induction with propofol, rocuronium, and remifentanil; maintenance with sevoflurane (1 MAC); ventilation targeting normocapnia; and postoperative reversal and extubation criteria. Clinical decision-making for vasoactive drug administration will follow predefined thresholds based on both blood pressure and rSO₂ monitoring criteria.
This study aims to provide pilot-level evidence on whether NVBP can reduce the need for radial arterial catheterization without compromising intraoperative safety or postoperative outcomes. If successful, NVBP may represent a less invasive, safer, and patient-friendly monitoring option for neurointerventional procedures, with broader implications for perioperative practice in patients where invasive arterial access is either undesirable or technically challenging.
- Conditions
- Cerebral Aneurysms, Intracranial Aneurysms, Coil Embolization, Hemodynamic Instability, Noninvasive Cardiac Monitoring
- Being tested
- Non-invasive continuous blood pressure monitoring, Invasive arterial blood pressure monitoring
- Keywords
- non-invasive blood pressure monitoring, continuous arterial blood pressure monitoring, coil embolization, neuroanesthesia, cerebral oximetry, radial arterial catheterization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive continuous blood pressure monitoringDevice
Continuous arterial blood pressure monitoring using a finger-cuff technology (e.g., ClearSight system). Applied in the experimental NVBP group.
Invasive arterial blood pressure monitoringDevice
Standard radial arterial catheterization for continuous invasive blood pressure monitoring. Applied in the IABP control group.
| Study group | Role | What they receive |
|---|---|---|
| NVBP group | Experimental | Participants undergo continuous non-invasive blood pressure (NVBP) monitoring using the ClearSight system (Edwards Lifesciences, Irvine, CA, USA) during coil embolization for intracranial aneurysm. Cerebral oxygen saturation is simultaneously monitored with O₃® Regional Oximetry (Masimo, CA, USA). A femoral arterial catheter placed for endovascular access may serve as a backup for safety, but invasive radial arterial catheterization is not performed. Receives: Device: Non-invasive continuous blood pressure monitoring |
| IABP group | Active comparator | Participants undergo standard invasive arterial blood pressure (IABP) monitoring via radial arterial catheterization during coil embolization. Cerebral oxygen saturation is also monitored with O₃® Regional Oximetry (Masimo, CA, USA), identical to the NVBP group. Receives: Device: Invasive arterial blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural hemodynamic instability events (hypotension or hypertension events)
Incidence of hemodynamic instability during coil embolization. Hypotension is defined as mean arterial pressure (MAP) < 65 mmHg sustained for ≥ 1 minute. Hypertension is defined as systolic arterial pressure > 120 mmHg sustained for ≥ 1 minute.
Measured: During the procedure (Day 0)
Secondary outcomes (9)
Use of vasoactive medications
Name of vasoactive medications (vasopressors or antihypertensives) administered during the procedure
Measured: During the procedure (Day 0)
Dose of vasoactive medications (vasopressors or antihypertensives)
cumulative dose of vasoactive medications administered during the procedure.
Measured: During the procedure (Day 0)
Cerebral oxygen desaturation events
Incidence of cerebral oxygen desaturation, defined as ≥20% decrease from baseline or an absolute value <50 for ≥1 minute, measured by near-infrared spectroscopy (NIRS).
Measured: During the procedure (Day 0)
Length of hospital stay
Duration (day) of hospitalization after coil embolization until discharge.
Measured: Discharge day (typically postoperative 2 - 14 days)
Incidence of ICU admission
Incidence of ICU admission after embolization between two groups
Measured: Discharge day (typically postoperative 2 - 7 days)
length of stay in ICU
duration of ICU stay (day)
Measured: Discharge day (typically postoperative 2 - 7 days)
30-day mortality
All-cause mortality within 30 days after the procedure.
Measured: Postoperative Day 30
Major complications within 30 days
Incidence of neurological complications, cardiovascular complications, and acute kidney injury (KDIGO criteria).
Measured: Postoperative Day 30
Event detection rate of NVBP vs IABP
Comparison of the ability of non-invasive blood pressure monitoring vs invasive arterial blood pressure monitoring to detect hypotension, hypertension, or cerebral desaturation events.
Measured: Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio into two parallel groups: the experimental arm (non-invasive blood pressure monitoring using ClearSight system) and the control arm (invasive radial arterial catheter monitoring).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JangHun Kim, Korea University Anam Hospital
- Investigators
- Jang Hoon Kim, M.D., Ph.D., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246148
- Sponsor's protocol ID
- K2025-2494-001
- Acronym
- NOVA
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for IPD sharing has not been finalized. Although de-identified data may be valuable for future research, the study is investigator-initiated at a single center and does not currently have a secure platform for external data sharing. Data sharing may be reconsidered in the future after publication, depending on institutional policies and available resources.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Non-Invasive Continuous Blood Pressure Monitoring as an Alternative to Radial Arterial Catheterization in Patients Undergoing Coil Embolization for Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT07246148
- Acronym / sponsor ID
- NOVA / K2025-2494-001
- Conditions
- Cerebral Aneurysms, Intracranial Aneurysms, Coil Embolization, Hemodynamic Instability, Noninvasive Cardiac Monitoring
- Keywords
- non-invasive blood pressure monitoring, continuous arterial blood pressure monitoring, coil embolization, neuroanesthesia, cerebral oximetry, radial arterial catheterization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Nov 2025 (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 goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms.
The main questions it aims to answer are:
- Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP?
- Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes?
Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring.
Participants will:
- Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization.
- Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂).
- Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols.
- Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.
Detailed description
Intracranial aneurysm coil embolization is a widely accepted treatment for unruptured aneurysms, but the procedure is frequently accompanied by hemodynamic instability, particularly episodes of hypotension and hypertension, which may increase the risk of neurological or cardiovascular complications. Continuous and reliable arterial blood pressure monitoring is therefore critical during the periprocedural period.
The conventional standard of care has been invasive arterial blood pressure (IABP) monitoring using a radial arterial catheter. Although IABP provides accurate real-time hemodynamic data, it is associated with procedural risks such as bleeding, hematoma, arterial occlusion, distal ischemia, infection, and patient discomfort. These risks are particularly relevant in patients undergoing neuroendovascular procedures where vascular access and anticoagulation may already increase complication risk.
The ClearSight™ system (Edwards Lifesciences, Irvine, CA, USA) is a non-invasive continuous blood pressure monitoring device that uses a finger cuff based on the volume clamp method and pulse contour analysis. Previous studies have validated its use in a variety of surgical and perioperative settings, including obese patients, vascular surgery, and cardiac surgery [Kim et al., 2014; Maheshwari et al., 2018; Bugarini et al., 2021; Chapalain et al., 2024]. However, its role as a primary monitoring modality during neuroendovascular procedures has not been fully established.
This randomized controlled trial (NOVA study) is designed to determine whether non-invasive continuous blood pressure monitoring (NVBP) can serve as a safe and effective alternative to radial IABP in patients undergoing coil embolization for unruptured intracranial aneurysms. Patients will be randomized in a 1:1 ratio to receive either NVBP monitoring (experimental arm) or standard IABP monitoring (control arm). All participants will also undergo cerebral oxygenation monitoring with O₃® Regional Oximetry (Masimo, CA, USA) to detect potential cerebral desaturation events.
In the NVBP group, invasive arterial pressure will not be obtained from a radial catheter but may be secondarily recorded from a femoral arterial catheter used for the endovascular procedure itself. Importantly, the femoral arterial waveform will not be displayed to the anesthesiologist but will be recorded by nursing staff to ensure patient safety and allow for event adjudication if NVBP and IABP values diverge significantly.
The primary endpoint of this study is the intraoperative incidence of hemodynamic events, defined as episodes of hypotension (mean arterial pressure <65 mmHg sustained for ≥1 minute) or hypertension (systolic blood pressure >120 mmHg sustained for ≥1 minute). Secondary endpoints include vasopressor and antihypertensive drug use (type, dose, frequency), incidence of cerebral desaturation events (≥20% reduction from baseline or absolute rSO₂ <50), ICU admission and length of stay, overall hospital length of stay, 30-day mortality, reoperation rate, and incidence of major postoperative complications (neurologic, cardiovascular, or acute kidney injury).
To minimize performance bias, intraoperative management will follow a standardized anesthetic protocol including induction with propofol, rocuronium, and remifentanil; maintenance with sevoflurane (1 MAC); ventilation targeting normocapnia; and postoperative reversal and extubation criteria. Clinical decision-making for vasoactive drug administration will follow predefined thresholds based on both blood pressure and rSO₂ monitoring criteria.
This study aims to provide pilot-level evidence on whether NVBP can reduce the need for radial arterial catheterization without compromising intraoperative safety or postoperative outcomes. If successful, NVBP may represent a less invasive, safer, and patient-friendly monitoring option for neurointerventional procedures, with broader implications for perioperative practice in patients where invasive arterial access is either undesirable or technically challenging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio into two parallel groups: the experimental arm (non-invasive blood pressure monitoring using ClearSight system) and the control arm (invasive radial arterial catheter monitoring).
| Arm | Type | Receives |
|---|---|---|
| NVBP group | Experimental | Device: Non-invasive continuous blood pressure monitoringParticipants undergo continuous non-invasive blood pressure (NVBP) monitoring using the ClearSight system (Edwards Lifesciences, Irvine, CA, USA) during coil embolization for intracranial aneurysm. Cerebral oxygen saturation is simultaneously monitored with O₃® Regional Oximetry (Masimo, CA, USA). A femoral arterial catheter placed for endovascular access may serve as a backup for safety, but invasive radial arterial catheterization is not performed. |
| IABP group | Active comparator | Device: Invasive arterial blood pressure monitoringParticipants undergo standard invasive arterial blood pressure (IABP) monitoring via radial arterial catheterization during coil embolization. Cerebral oxygen saturation is also monitored with O₃® Regional Oximetry (Masimo, CA, USA), identical to the NVBP group. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥19 and ≤80 years old) scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
Key exclusion criteria (6 listed)
- Patients who do not provide informed consent.
- Patients unable to understand or follow study instructions due to physical or mental limitations.
- Patients in whom radial arterial catheterization is not feasible (e.g., peripheral vascular disease, skin disorders at the insertion site, absence of radial/ulnar artery, or orthopedic conditions of the upper extremity).
- Patients with peripheral vascular circulatory disorders.
- Patients with morbid obesity (BMI ≥ 40 kg/m²) [Eley et al., 2021].
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 |
|---|---|---|
| Non-invasive continuous blood pressure monitoringContinuous arterial blood pressure monitoring using a finger-cuff technology (e.g., ClearSight system). Applied in the experimental NVBP group. | Device | NVBP group |
| Invasive arterial blood pressure monitoringStandard radial arterial catheterization for continuous invasive blood pressure monitoring. Applied in the IABP control group. | Device | IABP group |
Primary outcome
Intra-procedural hemodynamic instability events (hypotension or hypertension events)
Time frame: During the procedure (Day 0)
Incidence of hemodynamic instability during coil embolization. Hypotension is defined as mean arterial pressure (MAP) < 65 mmHg sustained for ≥ 1 minute. Hypertension is defined as systolic arterial pressure > 120 mmHg sustained for ≥ 1 minute.
9 secondary outcomes
Use of vasoactive medications
Time frame: During the procedure (Day 0)
Dose of vasoactive medications (vasopressors or antihypertensives)
Time frame: During the procedure (Day 0)
Cerebral oxygen desaturation events
Time frame: During the procedure (Day 0)
Length of hospital stay
Time frame: Discharge day (typically postoperative 2 - 14 days)
Incidence of ICU admission
Time frame: Discharge day (typically postoperative 2 - 7 days)
length of stay in ICU
Time frame: Discharge day (typically postoperative 2 - 7 days)
30-day mortality
Time frame: Postoperative Day 30
Major complications within 30 days
Time frame: Postoperative Day 30
Event detection rate of NVBP vs IABP
Time frame: Postoperative Day 30
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 9 Apr 2026.
- Individual participant dataSharing planned: Undecided. The plan for IPD sharing has not been finalized. Although de-identified data may be valuable for future research, the study is investigator-initiated at a single center and does not currently have a secure platform for external data sharing. Data sharing may be reconsidered in the future after publication, depending on institutional policies and available resources.
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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.
Jang Hoon Kim, M.D., Ph.D. principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive continuous blood pressure monitoring and Invasive arterial blood pressure monitoring in people with Cerebral Aneurysms and Intracranial Aneurysms, run by Korea University Anam Hospital at 1 site in South Korea.
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 2 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: looking for participants now, as of the sponsor's last update on 9 Apr 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 South Korea. 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 Eunji Ko, M.D., Ph.D. (+82-10-3423-8249, froken.ko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural hemodynamic instability events (hypotension or hypertension events) (time frame: During the procedure (Day 0)). 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 9 Apr 2026.