An interventional study of Intracranial stenting and Continuation of conventional endovascular therapy (EVT) in Stroke, Stroke, Acute Ischemic and Intracranial Atherosclerosis, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
The goal of this international, multi-center, randomized clinical trial is to compare two treatment options, early intracranial stenting and continued stent-retriever or aspiration based endovascular treatment, for stroke patients with a large vessel occlusion, who experienced failure of recanalisation after initial treatment due to intracranial atherosclerosis.
This clinical tiral focuses on comparing treatment options for patients with an acute ischemic stroke, which is a significant cause of death and disability worldwide. Currently, endovascular treatment (EVT) is the gold standard for the removal of large blood clots in the brain arteries (large vessel occlusion, LVO), but sometimes it fails to reopen blocked blood vessels, especially when caused by an underlying intracranial atherosclerosis (ICAD). When restoring blood flow fails, patients' outcomes are much worse, with more than 70% experiencing severe disability or death.
One potential solution for these cases is intracranial stenting, where a stent is permanently implanted in the affected blood vessel to restore blood flow to the brain. This approach has shown promise in other conditions like myocardial infarction. However, there is an ongoing debate whether the benefits are offset by possibly higher bleeding risk, and current guidelines don't provide clear recommendations on the use of intracranial stenting.
Therefore, this study aims to compare the clinical efficacy and safety of early intracranial stenting versus continued conventional EVT (stent-retriever or aspiration based) in LVO stroke patients who haven't responded to conventional EVT due to ICAD.
The results of this clinical trial will offer high quality clinical evidence to determine whether intracranial stenting provides benefits over conventional EVT for LVO stroke patients experiencing recanalisation failure due to ICAD.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 498 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
In patients within the intervention group, the treating physician attempts to perform intracranial stenting (with or without balloon dilation).
Procedure: Intracranial stenting
In patients within the control group, the treating physician does not perform intracranial stenting and/or balloon dilation. Conventional endovascular therapy will be continued.
Procedure: Continuation of conventional endovascular therapy (EVT)
Intracranial stenting (+/- balloon dilatation) will be performed. Decisions regarding intracranial stenting are solely made by the treating physician. This means in specific, that the treating physician decides based on his/her judgement or based on local standards (as reported in the literature) on the devices and/or concomitant medications (including infusion/administration of antiplatelet medicine) used for intracranial stenting.
Patients undergo either (a) continued stent retriever or contact aspiration based endovascular treatment manoeuvres, (b) infusion/administration of antiplatelet medication or (c) stop of the procedure depending on local standard treatment approaches.
Assessment whether intracranial stenting compared to conventional endovascular treatment is beneficial regarding patient's functional status
To evaluate whether intracranial stenting compared to conventional endovascular treatment is beneficial, the degree of disability and dependency in everyday life is measured with the modified Rankin Scale (mRS), which is a standard tool to assess the neurological outcome in trials with acute severe brain disease. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability. The assessment of mRS is performed by an independent and blinded person that is certified for scoring the mRS.
Time frame: 90 days post randomization
Change in the National Institutes of Health Stroke Scale (NIHSS) score
To compare the impact of the two treatment options on the neurological deficit of the patient, the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and post randomization is evaluated. The NIHSS is a standard tool to assess the severity of stroke symptoms. The NIHSS ranges from 0 to 42 with less values indicating less neurological deficit.
Time frame: Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization
Assessment of the discharge location
The discharge location is assessed at the follow-up visit 90 days after randomization. Discharge location could either be: (a) other hospital, (b) rehabilitation facility, (c) nursing home, (d) residential home or (e) own household.
Time frame: 90 days post randomization
Assessment of the cognitive function
To assess the cognitive function, the validated Montreal Cognitive Assessment (MoCA) is used at the follow-up visit 90 days after randomization. If the patient cannot perform the test or is deceased, his/her score is rated as minimal. Scores range from 0 to 30 with higher scores indicating better cognitive function. A score of 26 or above indicates normal cognitive function.
Time frame: 90 days post randomization
Assessment of the quality of life
To assess the quality of life, the standardized questionnaire, EuroQol-5d, is used at 90 and 365 days after randomization. At 365 days the assessment is conduct as a telephone interview.
Time frame: 90 and 365 days post randomization
Assessment of disability and dependency in everyday live activities
To assess the functional outcome, the modified Rankin Scale (mRS) is measured after 365 days via a telephone interview. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability.
Time frame: 365 days post randomization
Assessment of the residential status
To assess the patient's residential status, a telephone interview with the patient or if not available his next of kin/caregiver is performed 365 days after the randomization.
Time frame: 365 days post randomization
Symptomatic intracranial haemorrhage (sICH)
The incidence of Symptomatic intracranial haemorrhage (sICH) is assessed based on the modified Safe Implementation of Treatments in Stroke-Monitoring Study (SITS-MOST) criteria. The SITS-MOST criteria define sICH as a parenchymal hematoma grade 1 or 2, indicated by an increase of at least 4 points on the National institute of Health Stroke Scale (NIHSS) (compared to the lowest recorded NIHSS post randomization). sICH is the main safety outcome in most stroke trials.
Time frame: 0-24 hours post randomization
Percentage of penumbral tissue saved (imaging based outcome parameter)
Percentage of penumbral tissue saved, which is defined as the proportion of tissue at risk at baseline that did not progress to infarction at 24 hours after randomization.
Time frame: 0 - 24 hours post randomization
Grading of reperfusion at the end of the intervention (imaging based outcome parameter)
The modified Thrombolysis In Cerebral Infarction (mTICI) score will be used to grade the reperfusion success at the end of the procedure. mTICI ranges from 0 (no reperfusion) to 3 (full reperfusion)
Time frame: 0 - 60 minutes post randomization
Grading of recanalization at 24 hours after the randomization (imaging based outcome parameter)
The arterial occlusion lesion scale will be used to grade the vessel status at 24 hours after randomization on a CT-angiography or MR-angiography (if done according to local standards of care). It ranges from 0 to 3 with 0 indicating no recanalization and 3 complete recanalization.
Time frame: 24 hours post randomization
Serious Adverse Events (SAEs)
The SAEs are assessed by a neurologist. The patient is asked if he/she has had any health problems since the last study visit. In addition, the patient's medical record is reviewed. If the patient is unable to come to the clinical visit at 90 days, he/she will be contacted by telephone. If patients/relatives do not respond, the general practitioner or treating physician will be contacted.
Time frame: 24 hours, 7-10 days, and 90 days post randomization
All-cause mortality
To assess the safety of the two treatment options, the mortality is determined.
Time frame: 7-10 days, 90 days, and 365 days post randomization
Reoccurrence of ischemic stroke in the same territory
The assessment of reoccurrence of ischemic stroke in the same territory is based on the clinical evaluation of the patient and imaging findings.
Time frame: 0-90 days post randomization
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University Hospital, Basel, Switzerland