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NCT Number: NCT06691230

PeRfusiOn Post tHrombEcTomy (PROPHET)

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.

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Key information

Conditions

Stroke, Acute, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Detection of New Potentially Clinically Relevant Findings on FDCTP

    Time frame: Up to 30 days post-procedure

    • 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.

Secondary outcomes

  1. Diagnostic Sensitivity of 2D DSA vs. FDCTP in Detecting Residual Vessel Occlusion

    Time frame: Up to 30 days post-procedure

    Proportion of patients with all detected residual vessel occlusions on FDCTP versus none or not all detected residual vessel occlusions on FDCTP (dichotomous outcome)

Other outcomes

  1. Eloquence of Hypoperfused Tissue

    Time frame: Up to 30 days post-procedure

    Hypoperfusion in the eloquent brain zones i.e. eloquent cortex (dichotomous variable: yes versus no)

  2. Concordance between FDCTP and standard imaging

    Time frame: Up to 30 days post-procedure

    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)

  3. Prevalence of the No-Reflow Phenomenon on FDCTP

    Time frame: Up to 30 days post-procedure

    Proportion of patients with/without residual microvascular hypoperfusion (dichotomous variable).

  4. Detection of Competitive Leptomeningeal Flow on FDCTP

    Time frame: Up to 30 days post-procedure

    American Society of Interventional and Therapeutic Neuroradiology Collateral Grading System (categorical variable, Score 0-4)

  5. Cost-effectiveness of FDCTP

    Time frame: Up to 30 days post-procedure

    Incremental cost-effectiveness ratio (ICER, continuous variable)

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Kaesmacher, Prof.

CONTACT

[email protected]

+41 31 66 4 05 38

Seraina Beyeler, PhD

CONTACT

[email protected]

+41 31 632 39 70

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

PeRfusiOn Post tHrombEcTomy (PROPHET) A Prospective Observational Cohort Study

Acronym: PROPHET

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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