Stroke, Acute, IschemicPROPHETNCT06691230
PeRfusiOn Post tHrombEcTomy (PROPHET)
An observational study of Stroke, Acute, Ischemic, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Ischemic
- How many people
- 279 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2024to 28 Feb 2028
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
University Hospital Basel
Basel, 4031
Marios Psychogios, Prof., +41 61 328 59 36, marios.psychogios@usb.ch
Marios Psychogios, Prof.
- Recruiting
University Hospital Bern
Bern, 3010
Johannes Kaesmacher, Prof., +41 31 66 4 05 38, johannes.kaesmacher@insel.ch
Johannes Kaesmacher, Prof.
About this study
Official title: PeRfusiOn Post tHrombEcTomy (PROPHET) A Prospective Observational Cohort Study
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.
Read the detailed description
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.
- Conditions
- Stroke, Acute, Ischemic
- Keywords
- Acute ischemic stroke, Large-vessel occlusion, Endovascular mechanical thrombectomy, Flat-panel detector computed tomography perfusion imaging, Perfusion imaging
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Flat-panel detector computed tomography perfusion imaging, FDCTP | Potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days post-procedure
Secondary 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)
Measured: Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Nov 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute, IschemicStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Kaesmacher, Prof., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691230
- Sponsor's protocol ID
- 2024-01108
- Acronym
- PROPHET
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRfusiOn Post tHrombEcTomy (PROPHET) A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06691230
- Acronym / sponsor ID
- PROPHET / 2024-01108
- Conditions
- Stroke, Acute, Ischemic
- Keywords
- Acute ischemic stroke, Large-vessel occlusion, Endovascular mechanical thrombectomy, Flat-panel detector computed tomography perfusion imaging, Perfusion imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 15 Nov 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flat-panel detector computed tomography perfusion imaging, FDCTP | – | –Potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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
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.
1 secondary outcome
Diagnostic Sensitivity of 2D DSA vs. FDCTP in Detecting Residual Vessel Occlusion
Time frame: Up to 30 days post-procedure
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 15 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Johannes Kaesmacher, Prof. principal investigator
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, Ischemic, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 3 inclusion and 2 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 15 Nov 2024. 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 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 Johannes Kaesmacher, Prof. (+41 31 66 4 05 38, nctu@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of New Potentially Clinically Relevant Findings on FDCTP (time frame: Up to 30 days post-procedure). 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 15 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.