ThrombectomyPhase 4NCT05155540
Direct Mechanical Thrombectomy Versus Bridging Therapy
A Phase 4 study testing Trevo and or Merci devices for stent retreival, Penumbra system for stent aspiration and recombinant tissue plasminogen activator in people with Thrombectomy and Ischemic Stroke, run by Alexandria University at 1 site in Egypt.
Trial summary
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombectomy, Ischemic Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis)
- What is being tested?
- Trevo and or Merci devices for stent retreival, Penumbra system for stent aspiration and recombinant tissue plasminogen activator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Sep 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior ischemic stroke due to large vessel occlusion.
- A previous autonomous modified Rankin Scale (mRS) of less than 2.
- A National Institutes of Health Stroke Scale (NIHSS)≥4
- A groin puncture within 4.5 hours of the neurological deficit onset.
Who cannot join
- Imaging documentation of intracranial haemorrhage
- A premorbid mRS score of 2 or more
- Absence of diffusion perfusion mismatch in CT perfusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.
Read the detailed description
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.
- Being tested
- Trevo and or Merci devices for stent retreival, Penumbra system for stent aspiration, recombinant tissue plasminogen activator
- Keywords
- ischemic stroke, Direct mechanical thrombectomy, Bridging therapy
- Medical subject headings
- Ischemic Stroke, Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trevo and or Merci devices for stent retreivalDevice
Also called No other names
FDA approved devices for stent retrieval during mechanical thrombectomy
Penumbra system for stent aspirationDevice
FDA approved devices for stent aspiration during mechanical thrombectomy
recombinant tissue plasminogen activatorDrug
FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset
| Study group | Role | What they receive |
|---|---|---|
| Direct mechanical thrombectomy | Active comparator | Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator. Receives: Device: Trevo and or Merci devices for stent retreival; Device: Penumbra system for stent aspiration |
| Bridging therapy | Active comparator | Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg Receives: Device: Trevo and or Merci devices for stent retreival; Device: Penumbra system for stent aspiration; Drug: recombinant tissue plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score
A measurement of functional independence following ischemic stroke
Measured: 3 months
Complication rate
The rate and type of complications occuring postoperatively
Measured: within one week postoperatively
Secondary outcomes (1)
The National Institutes of Health Stroke Scale (NIHSS) score
A validated scale for assessment of neurological dysfunction associated with stroke
Measured: at 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombectomyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, non-randomized, prospective, double-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Anwar, Alexandria University
- Investigators
- Mohamed A Abdel Ghani, Master's, Principal investigator, Alexandria University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155540
- Sponsor's protocol ID
- 0201218
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience
- ClinicalTrials.gov ID
- NCT05155540
- Acronym / sponsor ID
- 0201218
- Keywords
- ischemic stroke, Direct mechanical thrombectomy, Bridging therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 13 Dec 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.
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.
Detailed description
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, non-randomized, prospective, double-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Direct mechanical thrombectomy | Active comparator | Device: Trevo and or Merci devices for stent retreival, Device: Penumbra system for stent aspirationDirect mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator. |
| Bridging therapy | Active comparator | Device: Trevo and or Merci devices for stent retreival, Device: Penumbra system for stent aspiration, Drug: recombinant tissue plasminogen activatorMechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with anterior ischemic stroke due to large vessel occlusion.
- A previous autonomous modified Rankin Scale (mRS) of less than 2.
- A National Institutes of Health Stroke Scale (NIHSS)≥4
- A groin puncture within 4.5 hours of the neurological deficit onset.
Key exclusion criteria (3 listed)
- Imaging documentation of intracranial haemorrhage
- A premorbid mRS score of 2 or more
- Absence of diffusion perfusion mismatch in CT perfusion.
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 |
|---|---|---|
| Trevo and or Merci devices for stent retreivalAlso: No other namesFDA approved devices for stent retrieval during mechanical thrombectomy | Device | Bridging therapy, Direct mechanical thrombectomy |
| Penumbra system for stent aspirationFDA approved devices for stent aspiration during mechanical thrombectomy | Device | Bridging therapy, Direct mechanical thrombectomy |
| recombinant tissue plasminogen activatorFDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset | Drug | Bridging therapy |
Primary outcome
Modified Rankin Scale score
Time frame: 3 months
A measurement of functional independence following ischemic stroke
Complication rate
Time frame: within one week postoperatively
The rate and type of complications occuring postoperatively
1 secondary outcome
The National Institutes of Health Stroke Scale (NIHSS) score
Time frame: at 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon request
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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.
Mohamed A Abdel Ghani, Master's principal investigator
Alexandria University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trevo and or Merci devices for stent retreival, Penumbra system for stent aspiration and recombinant tissue plasminogen activator in people with Thrombectomy and Ischemic Stroke, run by Alexandria University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Rankin Scale score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 3 Jan 2022.