An observational study in Stroke, Acute, Ischemic, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
Endovascular mechanical thrombectomy is the standard of care for treating patients with a large-vessel occlusion acute ischemic stroke. However, in more than half of these patients, remaining distal vessel occlusions limit the benefit of this therapy. Currently the detection of residual vessel occlusions and the decision for further treatment by the operator is based on the 2D digital subtraction angiography (DSA) images. However, this technique has several limitations. Recently, a new imaging technique, with the possibility to acquire 3D time-resolved perfusion images directly in the operating room was introduced (the flat-panel detector computed tomography perfusion imaging, FDCTP). It can overcome the spatial limitations of 2D DSA, but the details on clinical validation and utility of FDCTP are currently lacking.
This clinical investigation is planned as a multi-center, prospective, non-randomized observational study with a primary endpoint to evaluate a potential diagnostic benefit. The diagnostic tool to be studied is clinically indicated 60s Dyna CT Head Perfusion (FDCTP imaging) obtained after or during mechanical thrombectomy for acute ischemic stroke.
The population consists of patients with symptoms of acute ischemic stroke, who were intended to undergo mechanical thrombectomy. This means that patients who did not undergo mechanical thrombectomy and only had diagnostic angiography (e.g. physician team has decided against thrombectomy due to pre-interventional vessel reperfusion), can still be included in the study. Patients can only be included if a FDCTP was acquired immediately after thrombectomy or diagnostic angiography by the treating physician team as part of the standard clinical routine. There is no control group.
The overall objective is to investigate the potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment. Primary study objective is to evaluate in how many cases FDCTP maps reveal new, potentially relevant clinical information that may change treatment decisions. The primary research hypothesis is that the proportion of patients where FDCTP reveals new, potentially clinically relevant findings is greater than 25%. Assuming a true proportion of 33% of the primary outcome, we will need 251 patients to reach a power of 80% at a one-sided alpha of 2.5%, based on a one-sample binomial exact test. To account for a drop-out rate of 10%, we plan to recruit 279 patients.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 279 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Patients with an acute ischemic stroke with large vessel occlusion who have undergone endovascular mechanical thrombectomy and received a (flat-panel detector computed tomography perfusion imaging (FDCTP) shortly after the treatment.
Exclusion Criteria:
Potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment
Detection of New Potentially Clinically Relevant Findings on FDCTP
* Any hypoperfusion on processed FDCTP maps suggesting residual vessel occlusion within the target mechanical thrombectomy territory, not noted on the 2D DSA imaging (dichotomous variable: yes versus no) * Any hypoperfusion suggestive of vessel occlusion outside the target mechanical thrombectomy territory not observed on the 2D DSA i.e., a new vessel occlusion (dichotomous variable: yes versus no) * No hypoperfusion suggestive of residual vessel occlusion on FDCTP within the target mechanical thrombectomy territory, even thought the patient has incomplete reperfusion (\<eTICI3) on the 2D DSA (dichotomous variable: yes versus no) The primary outcome of the study will be assessed as a dichotomous variable (yes versus no), derived from a compound measure of clinically relevant findings based on the three interpretations described above.
Time frame: Up to 30 days post-procedure
Diagnostic Sensitivity of 2D DSA vs. FDCTP in Detecting Residual Vessel Occlusion
Proportion of patients with all detected residual vessel occlusions on FDCTP versus none or not all detected residual vessel occlusions on FDCTP (dichotomous outcome)
Time frame: Up to 30 days post-procedure
Eloquence of Hypoperfused Tissue
Hypoperfusion in the eloquent brain zones i.e. eloquent cortex (dichotomous variable: yes versus no)
Time frame: Up to 30 days post-procedure
Concordance between FDCTP and standard imaging
Association of findings from the FDCTP with standard cross-sectional imaging on follow-up examination at 24 hours (categorical variable: sustained reperfusion, persisting perfusion deficit, delayed reperfusion)
Time frame: Up to 30 days post-procedure
Prevalence of the No-Reflow Phenomenon on FDCTP
Proportion of patients with/without residual microvascular hypoperfusion (dichotomous variable).
Time frame: Up to 30 days post-procedure
Detection of Competitive Leptomeningeal Flow on FDCTP
American Society of Interventional and Therapeutic Neuroradiology Collateral Grading System (categorical variable, Score 0-4)
Time frame: Up to 30 days post-procedure
Cost-effectiveness of FDCTP
Incremental cost-effectiveness ratio (ICER, continuous variable)
Time frame: Up to 30 days post-procedure
Plan to share: Undecided
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Insel Gruppe AG, University Hospital Bern