Ischemic StrokeRESISTANCENCT07566598
Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution
A study testing Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution in people with Ischemic Stroke, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Worldwide, cerebrovascular accidents (also known as strokes) are the leading cause of acquired disability, the second-leading cause of dementia (after Alzheimer's disease) and the second-leading cause of death (but the leading cause of death among women). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2026to Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 80
- Social Security beneficiaries
- Obtained signed consent to participate in the study
- TICI 2c or TICI 3 score after mechanical thrombectomy
- Patients hospitalized for ischemic stroke due to middle cerebral artery thrombosis
Who cannot join
- Spasm of an artery without significant stenosis
- Vessel diameter less than 1 mm
- Severe visceral failure
- Local infection
- Minors
- Adults protected by law
Show all 10Show fewer
- Patients deprived of their liberty
- Subjects who are uncooperative or unable to meet the requirements of the protocol
- Subjects participating in another clinical trial or in a period of exclusion from a previous clinical trial
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, Alpes-maritimes, 06000
Yves CHAU, PH, +33 4 92 03 35 90, chau.hd@chu-nice.fr
About this study
Official title: Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution: a Pilot Study - RESISTANCE
Worldwide, cerebrovascular accidents (also known as strokes) are the leading cause of acquired disability, the second-leading cause of dementia (after Alzheimer's disease) and the second-leading cause of death (but the leading cause of death among women). A mechanical thrombectomy (MT) allows the recanalization of the occluded cerebral artery during an acute ischemic stroke, by removing the blood clot with a mechanical device inserted endovascularly under image guidance. MTs are the optimal treatment for a large number of patients presenting an occlusion in an anterior artery (the internal carotid artery and the proximal segment of the middle cerebral artery). Reperfusion is considered satisfactory if the mTICI score at the end of the procedure is of mTICI 2c or mTICI 3. Despite these scores having been obtained by 71% of patients during the randomized trials, showing the superiority of MT over intravenous thrombolysis, only 27% of these patients were free of neurological deficits at 3 months . Therefore, there is a discrepancy between the high rate of macroscopic recanalization and clinical results. One hypothesis to explain this discrepancy is that despite high quality macroscopic recanalization, reperfusion of the cerebral microcirculation remains insufficient: macroscopic recanalization is not equivalent to microscopic reperfusion. This discrepancy also exists in cardiology: despite a high rate of coronary artery recanalization when patients with an ST- segment elevation myocardial infarction are in emergency care, half of these patients later exhibit coronary microvascular dysfunction. The absence of reperfusion is associated with an increased risk of cardiovascular death, recurring myocardial infarctions, cardiogenic shock and heart failure one year after the coronary recanalization for an ST-segment elevation myocardial infarction. It has been shown that continuous intracoronary thermodilution can be used to quantify coronary blood flow and the absolute value of microcirculatory resistance (in Wood units). There are not currently any tools that can quantify cerebral microcirculation immediately after an MT.
The aim of this study is to evaluate the feasibility and safety of using a pressure/temperature sensing guidewire to measure cerebral microcirculatory resistance using thermodilution in patients with a score of mTICI 2c or 3 after MT for the management of acute ischemic stroke in the anterior circulation.
- Conditions
- Ischemic Stroke
- Being tested
- Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring Absolute Cerebral Flow and Microvascular Resistance by ThermodilutionDevice
The measurements will be taken as follows: once satisfactory recanalization has been achieved (mTICI 2c or 3), the suction catheter will be placed at the origin of the M1 segment. Through this catheter, the pressure/temperature measurement microguide will be placed at the distal part of M1. The microcatheter will be placed on the microguide, with its tip positioned at the outlet of the aspiration catheter.
A pressure sensor will be connected to the aspiration catheter. The microcatheter will be connected to the saline injector programmed to inject saline. The microguide is replaced in the microcatheter 165 seconds after the start of the injection. The trace of the variation in parameters will be recorded on the Coroventis station. A control injection will be performed after removal of the microcatheter and microguide from the suction catheter to ensure that there are no complications due to the measurement.
| Study group | Role | What they receive |
|---|---|---|
| fully recanalization | Experimental | Not described Receives: Device: Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the feasibility of measuring cerebral blood flow and cerebral microcirculatory resistance using thermodilution with the rayflow microcatheter and pressurewire guide.
The primary evaluation criterion is the proportion of patients for whom measurements of cerebral blood flow and cerebral microcirculatory resistance using thermodilution were possible.
Measured: Immediately after the measurement of cerebral blood flow and cerebral microcirculatory resistance using thermodilution done with the pressure temperature guidewire
Secondary outcomes (4)
To assess the safety of using thermodilution to measure cerebral blood flow and cerebral microcirculatory resistance
The safety of the procedure will be evaluated by counting the number of deaths, perforations and dissections associated with the use of the guidewire and/or the microcatheter and/or the injection of physiological serum.
Measured: Immediately after the measurement of cerebral blood flow and cerebral microcirculatory resistance using thermodilution done with the pressure temperature guidewire
To describe the clinical evolution of patients
Complications will be reported according to the recommendations of the Cardiovascular and Interventional Radiological Society of Europe
Measured: DAY 90
Determine the threshold value of the cerebral microcirculation resistance index that allows the definition of an optimal sensitivity/specificity pair for the prognosis of neurological progression (favorable or not).
The value of the cerebral microcirculation resistance index for distinguishing between patients who will have a favorable neurological outcome (mRS ≤ 2) and those who will have an unfavorable outcome (mRS > 2) will be calculated from the ROC curve generated by the data collected.
Measured: day 90
Measure the additional radiation dose received by patient
The increase in the additional dose will be compared to that corresponding to the patient's usual treatment.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start7 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566598
- Sponsor's protocol ID
- 24-PP-08
- Acronym
- RESISTANCE
- Status last verified
- May 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution: a Pilot Study - RESISTANCE
- ClinicalTrials.gov ID
- NCT07566598
- Acronym / sponsor ID
- RESISTANCE / 24-PP-08
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 May 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.
Worldwide, cerebrovascular accidents (also known as strokes) are the leading cause of acquired disability, the second-leading cause of dementia (after Alzheimer's disease) and the second-leading cause of death (but the leading cause of death among women). A mechanical thrombectomy (MT) allows the recanalization of the occluded cerebral artery during an acute ischemic stroke, by removing the blood clot with a mechanical device inserted endovascularly under image guidance. MTs are the optimal treatment for a large number of patients presenting an occlusion in an anterior artery (the internal carotid artery and the proximal segment of the middle cerebral artery). Reperfusion is considered satisfactory if the mTICI score at the end of the procedure is of mTICI 2c or mTICI 3. Despite these scores having been obtained by 71% of patients during the randomized trials, showing the superiority of MT over intravenous thrombolysis, only 27% of these patients were free of neurological deficits at 3 months . Therefore, there is a discrepancy between the high rate of macroscopic recanalization and clinical results. One hypothesis to explain this discrepancy is that despite high quality macroscopic recanalization, reperfusion of the cerebral microcirculation remains insufficient: macroscopic recanalization is not equivalent to microscopic reperfusion. This discrepancy also exists in cardiology: despite a high rate of coronary artery recanalization when patients with an ST- segment elevation myocardial infarction are in emergency care, half of these patients later exhibit coronary microvascular dysfunction. The absence of reperfusion is associated with an increased risk of cardiovascular death, recurring myocardial infarctions, cardiogenic shock and heart failure one year after the coronary recanalization for an ST-segment elevation myocardial infarction. It has been shown that continuous intracoronary thermodilution can be used to quantify coronary blood flow and the absolute value of microcirculatory resistance (in Wood units). There are not currently any tools that can quantify cerebral microcirculation immediately after an MT.
The aim of this study is to evaluate the feasibility and safety of using a pressure/temperature sensing guidewire to measure cerebral microcirculatory resistance using thermodilution in patients with a score of mTICI 2c or 3 after MT for the management of acute ischemic stroke in the anterior circulation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fully recanalization | Experimental | Device: Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged 18 to 80
- Social Security beneficiaries
- Obtained signed consent to participate in the study
- TICI 2c or TICI 3 score after mechanical thrombectomy
- Patients hospitalized for ischemic stroke due to middle cerebral artery thrombosis
Key exclusion criteria (10 listed)
- Spasm of an artery without significant stenosis
- Vessel diameter less than 1 mm
- Severe visceral failure
- Local infection
- Minors
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 |
|---|---|---|
| Measuring Absolute Cerebral Flow and Microvascular Resistance by ThermodilutionThe measurements will be taken as follows: once satisfactory recanalization has been achieved (mTICI 2c or 3), the suction catheter will be placed at the origin of the M1 segment. Through this catheter, the pressure/temperature measurement microguide will be placed at the distal part of M1. The microcatheter will be placed on the microguide, with its tip positioned at the outlet of the aspiration catheter. A pressure sensor will be connected to the aspiration catheter. The microcatheter will be connected to the saline injector programmed to inject saline. The microguide is replaced in the microcatheter 165 seconds after the start of the injection. The trace of the variation in parameters will be recorded on the Coroventis station. A control injection will be performed after removal of the microcatheter and microguide from the suction catheter to ensure that there are no complications due to the measurement. | Device | fully recanalization |
Primary outcome
The primary objective is to assess the feasibility of measuring cerebral blood flow and cerebral microcirculatory resistance using thermodilution with the rayflow microcatheter and pressurewire guide.
Time frame: Immediately after the measurement of cerebral blood flow and cerebral microcirculatory resistance using thermodilution done with the pressure temperature guidewire
The primary evaluation criterion is the proportion of patients for whom measurements of cerebral blood flow and cerebral microcirculatory resistance using thermodilution were possible.
4 secondary outcomes
To assess the safety of using thermodilution to measure cerebral blood flow and cerebral microcirculatory resistance
Time frame: Immediately after the measurement of cerebral blood flow and cerebral microcirculatory resistance using thermodilution done with the pressure temperature guidewire
To describe the clinical evolution of patients
Time frame: DAY 90
Determine the threshold value of the cerebral microcirculation resistance index that allows the definition of an optimal sensitivity/specificity pair for the prognosis of neurological progression (favorable or not).
Time frame: day 90
Measure the additional radiation dose received by patient
Time frame: day 1
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 13 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring Absolute Cerebral Flow and Microvascular Resistance by Thermodilution in people with Ischemic Stroke, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 10 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 13 May 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 France. 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 Yves CHAU, MD (+33 4 92 03 35 90, chau.hd@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to assess the feasibility of measuring cerebral blood flow and cerebral microcirculatory resistance using thermodilution with the rayflow microcatheter and pressurewire guide. (time frame: Immediately after the measurement of cerebral blood flow and cerebral microcirculatory resistance using thermodilution done with the pressure temperature guidewire). 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 13 May 2026.