PeRfusiOn Post tHrombEcTomy (PROPHET)
ConditionStroke, Acute, Ischemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent as documented by a signature
The patients received mechanical thrombectomy or there was the intention to perform endovascular treatment, but only diagnostic angiography was performed.
Patients received FDCTP as clinically indicated by the treating physician.
Disqualifiers
Inability to give consent due to insufficient knowledge of the project language
Inability to follow the clinically indicated visit at 90 days after the index stroke (e.g. patients living abroad).
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
279 Participants
are grouped into 1 trial groupGroup A: Flat-panel detector computed tomography perfusion imaging, FDCTP
Trial outcomes
Primary outcomes
1
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-procedureSecondary outcomes
1
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-procedureOther outcomes
1
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-procedure2
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-procedure3
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-procedure4
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-procedureSponsors and contacts
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Source ClinicalTrials.gov