Stroke, Acute IschemicPhase 3NCT05091320
Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".
A Phase 3 study testing Mechanical thrombectomy and medical treatment in people with Stroke, Acute Ischemic, run by Assiut University.
Trial summary
Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Mechanical thrombectomy and medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
- With or without IV thrombolysis
- Access to endovascular treatment within 24 hours from onset.
Who cannot join
- Proven proximal occlusion of MCA.
- Disability prior to the stroke (mRS >3)
- Opposition of the patient or their family
About this study
Official title: Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial
Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
Read the detailed description
this study aims to:
- compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA.
- improve outcome of acute ischemic stroke.
The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups:
Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups
- Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group).
Study design:
All patients are subjected to the following: -
- Enrolled patients were admitted to stroke units or intensive care units.
- Intravenous t-PA was allowed if begun within < 4.5 hours after symptom onset.
- Thrombectomy will be performed with any FDA approved thrombectomy device by the use of local anesthesia (general anesthesia will be discouraged).
Imaging
- Patients presented with clinical picture and radiography suggestive of large vessel occlusion and who meet the proposed clinical criteria for EVT will be subjected to a comprehensive evaluation with:
- Arterial imaging of the cerebral circulation with preferably with CTA or alternatively with magnetic resonance angiography to
- Perfusion imaging with perfusion CT or with diffusion weighted imaging MRI can allow identification and quantification of the ischemic penumbra and, therefore, is useful for assessing patient eligibility for EVT in the extended time window.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Mechanical thrombectomy, medical treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyDrug
Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke
medical treatmentDrug
medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy | Active comparator | this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment. Receives: Drug: Mechanical thrombectomy; Drug: medical treatment |
| medical managemnet | Active comparator | this arm will include all patients who received medical treatment only, either anti-platelet or alteplase. Receives: Drug: medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical neurological outcome
Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
Measured: 3 months
Secondary outcomes (1)
Functional outcome
Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke.
Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Nageeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091320
- Sponsor's protocol ID
- Neurointervintion and stroke
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial
- ClinicalTrials.gov ID
- NCT05091320
- Acronym / sponsor ID
- Neurointervintion and stroke
- Conditions
- Stroke, Acute Ischemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 25 Oct 2021 (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.
Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
Detailed description
this study aims to:
- compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA.
- improve outcome of acute ischemic stroke.
The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups:
Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups
- Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group).
Study design:
All patients are subjected to the following: -
- Enrolled patients were admitted to stroke units or intensive care units.
- Intravenous t-PA was allowed if begun within < 4.5 hours after symptom onset.
- Thrombectomy will be performed with any FDA approved thrombectomy device by the use of local anesthesia (general anesthesia will be discouraged).
Imaging
- Patients presented with clinical picture and radiography suggestive of large vessel occlusion and who meet the proposed clinical criteria for EVT will be subjected to a comprehensive evaluation with:
- Arterial imaging of the cerebral circulation with preferably with CTA or alternatively with magnetic resonance angiography to
- Perfusion imaging with perfusion CT or with diffusion weighted imaging MRI can allow identification and quantification of the ischemic penumbra and, therefore, is useful for assessing patient eligibility for EVT in the extended time window.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- case control
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy | Active comparator | Drug: Mechanical thrombectomy, Drug: medical treatmentthis arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment. |
| medical managemnet | Active comparator | Drug: medical treatmentthis arm will include all patients who received medical treatment only, either anti-platelet or alteplase. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
- With or without IV thrombolysis
- Access to endovascular treatment within 24 hours from onset.
Key exclusion criteria (3 listed)
- Proven proximal occlusion of MCA.
- Disability prior to the stroke (mRS >3)
- Opposition of the patient or their family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical thrombectomyMechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke | Drug | Mechanical thrombectomy |
| medical treatmentmedical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet | Drug | Mechanical thrombectomy, medical managemnet |
Primary outcome
Clinical neurological outcome
Time frame: 3 months
Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
1 secondary outcome
Functional outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mechanical thrombectomy and medical treatment in people with Stroke, Acute Ischemic, run by Assiut University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical neurological outcome (time frame: 3 months). 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 25 Oct 2021.