Intracranial StenosisRe-CHILLNCT07072026
Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions
An observational study of Intracranial Stenosis and Intracranial Atherosclerotic Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
Trial summary
Background: Chronic intracranial large vessel occlusion (LVO), resulting from progressive atherosclerosis or thrombosis, contributes significantly to ischemic strokes, 8-10% in North America and up to 50% in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Stenosis, Intracranial Atherosclerotic Disease
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 May 2025to 31 Dec 2025
- Phase
- Observational
- 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
Study population: The intradural occlusion is defined as the occlusion entirely located or extended into an intradural vascular segment (e.g., ICA occlusion extending from the extradural ICA to the ophthalmic ICA segment). The ICA segments are defined as follows: * Extradural ICA segment - from the ICA origin until the distal dural ring * Ophthalmic ICA segment - from the distal dural ring right below the origin of the posterior communicating artery (PCOM) * Communicating ICA segment - right from the PCOM origin to the ICA termination (bifurcation) The symptomatic occlusion is defined as acute neurological impairment and/or acute ischemic stroke or hypoperfusion within the affected vascular territory detected on baseline imaging.
Who may be able to join
- all consecutive patients who undergone endovascular recanalization for chronic intradural large vessel occlusions between January 1st, 2020, and December 31st, 2024 involving the following locations: internal carotid artery (ICA), middle cerebral artery (MCA), vertebral artery (VA), and basilar artery (BA)
Who cannot join
- presence of documented written or verbal refusal
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Alfried Krupp Krankenhaus
Essen, 45131
Fatima Quaiser, Fatima.Qaiser@krupp-krankenhaus.de
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern, University Hospital Bern
Bern, 3010
Petra Cimflova, MD, PhD, +41316640831, petra.cimflova@insel.ch
About this study
Official title: Feasibility of Endovascular Recanalization for Symptomatic Chronic Intradural Large Vessel Occlusions - Re-CHILL Study
Background: Chronic intracranial large vessel occlusion (LVO), resulting from progressive atherosclerosis or thrombosis, contributes significantly to ischemic strokes, 8-10% in North America and up to 50% in the Chinese population. This condition leads to cerebral hypoperfusion, brain ischemia, and potentially cognitive impairment. While extra-to-intracranial bypass surgery has shown limited benefit, recent advances in endovascular treatment (EVT) for acute ischemic stroke show promise. Preliminary reports suggest EVT may be feasible for chronic intracranial artery occlusions. Still, outcomes vary and perioperative risks remain high, particularly for intradural occlusions, which are technically more challenging and less studied.
Objectives: This study aims to evaluate the feasibility, safety, and clinical outcomes of EVT for symptomatic chronic intradural large vessel occlusions. Primary endpoints include technical success, complication rates, and functional outcomes, as measured by the modified Rankin Scale (mRS) at 3 months and the last follow-up. Safety endpoints include mortality, ischemic stroke, and periprocedural complications.
Read more
Design: A multicenter, retrospective and prospective observational study involving 10-20 experienced centers worldwide. Data from approximately 40-80 patients treated between January 2020 and December 2024 will be collected by local neuroradiologists, neurologists, or neurosurgeons. Clinical data (demographics, comorbidities, symptoms, outcomes), imaging data (pre-, post-, and follow-up), procedural details, and medication regimens will be collected. Inclusion criteria target adult patients with symptomatic chronic intradural occlusions of key intracranial arteries (ICA, MCA, VA, BA). Symptomatic occlusion is defined by neurological deficits or imaging evidence of ischemia. The data analysis will be performed by the local team at the Inselspital, Bern, Switzerland.
Aim: To descriptively analyze patient characteristics, treatment approaches, complications, and hemodynamic changes post-EVT to inform future therapeutic strategies for this challenging condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome assesed by modified Rankin Scale
The primary outcome is the degree of dependency and disability in everyday life measured with the modified Rankin Score (mRS) at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Measured: at 3 months after endovascular treatment
Rate of technical success
Succesful versus failed recanalization; presence or absence of the residual stenosis
Measured: on the day of procedure
Secondary outcomes (3)
Clinical outcome at the last available follow-up assesssed by modified Rankin Score
Degree of dependency and disability in everyday life measured with the modified Rankin Score (mRS) . The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Measured: through study completion, an average of 1 year
Death during the initial hospital stay
Measured: from day 1 until discharge from hospital, on average of 7 days
Death at 3 months
occurence of death from day 1 up to 3 months
Measured: from day 1 up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start15 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial StenosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072026
- Sponsor's protocol ID
- 2025-00410
- Other IDs
- 2025
- Acronym
- Re-CHILL
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Endovascular Recanalization for Symptomatic Chronic Intradural Large Vessel Occlusions - Re-CHILL Study
- ClinicalTrials.gov ID
- NCT07072026
- Acronym / sponsor ID
- Re-CHILL / 2025-00410
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jul 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.
Background: Chronic intracranial large vessel occlusion (LVO), resulting from progressive atherosclerosis or thrombosis, contributes significantly to ischemic strokes, 8-10% in North America and up to 50% in the Chinese population. This condition leads to cerebral hypoperfusion, brain ischemia, and potentially cognitive impairment. While extra-to-intracranial bypass surgery has shown limited benefit, recent advances in endovascular treatment (EVT) for acute ischemic stroke show promise. Preliminary reports suggest EVT may be feasible for chronic intracranial artery occlusions. Still, outcomes vary and perioperative risks remain high, particularly for intradural occlusions, which are technically more challenging and less studied.
Objectives: This study aims to evaluate the feasibility, safety, and clinical outcomes of EVT for symptomatic chronic intradural large vessel occlusions. Primary endpoints include technical success, complication rates, and functional outcomes, as measured by the modified Rankin Scale (mRS) at 3 months and the last follow-up. Safety endpoints include mortality, ischemic stroke, and periprocedural complications.
Design: A multicenter, retrospective and prospective observational study involving 10-20 experienced centers worldwide. Data from approximately 40-80 patients treated between January 2020 and December 2024 will be collected by local neuroradiologists, neurologists, or neurosurgeons. Clinical data (demographics, comorbidities, symptoms, outcomes), imaging data (pre-, post-, and follow-up), procedural details, and medication regimens will be collected. Inclusion criteria target adult patients with symptomatic chronic intradural occlusions of key intracranial arteries (ICA, MCA, VA, BA). Symptomatic occlusion is defined by neurological deficits or imaging evidence of ischemia. The data analysis will be performed by the local team at the Inselspital, Bern, Switzerland.
Aim: To descriptively analyze patient characteristics, treatment approaches, complications, and hemodynamic changes post-EVT to inform future therapeutic strategies for this challenging condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intradural occlusion is defined as the occlusion entirely located or extended into an intradural vascular segment (e.g., ICA occlusion extending from the extradural ICA to the ophthalmic ICA segment). The ICA segments are defined as follows: * Extradural ICA segment - from the ICA origin until the distal dural ring * Ophthalmic ICA segment - from the distal dural ring right below the origin of the posterior communicating artery (PCOM) * Communicating ICA segment - right from the PCOM origin to the ICA termination (bifurcation) The symptomatic occlusion is defined as acute neurological impairment and/or acute ischemic stroke or hypoperfusion within the affected vascular territory detected on baseline imaging.
Key inclusion criteria (1 listed)
- all consecutive patients who undergone endovascular recanalization for chronic intradural large vessel occlusions between January 1st, 2020, and December 31st, 2024 involving the following locations: internal carotid artery (ICA), middle cerebral artery (MCA), vertebral artery (VA), and basilar artery (BA)
Key exclusion criteria (1 listed)
- presence of documented written or verbal refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome assesed by modified Rankin Scale
Time frame: at 3 months after endovascular treatment
The primary outcome is the degree of dependency and disability in everyday life measured with the modified Rankin Score (mRS) at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Rate of technical success
Time frame: on the day of procedure
Succesful versus failed recanalization; presence or absence of the residual stenosis
3 secondary outcomes
Clinical outcome at the last available follow-up assesssed by modified Rankin Score
Time frame: through study completion, an average of 1 year
Death during the initial hospital stay
Time frame: from day 1 until discharge from hospital, on average of 7 days
Death at 3 months
Time frame: from day 1 up to 3 months
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 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Stenosis and Intracranial Atherosclerotic Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
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 1 inclusion and 1 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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 Petra Cimflova, MD, PhD (+41316640831, petra.cimflova@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome assesed by modified Rankin Scale (time frame: at 3 months after endovascular treatment). 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 18 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.