Stroke, IschemicPhase 4VasInterventNCT04393025
Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)
A Phase 4 study testing Intracranial Stenting by Intracranial Stent Device and Optimum medical treatment in people with Stroke, Ischemic, run by Ain Shams University.
Trial summary
Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Intracranial Stenting by Intracranial Stent Device and Optimum medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2019
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 30-80 years.
- Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA).
- Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia).
Who cannot join
- Patients previously stented at the target lesion or had extracranial stenosis.
- Patient with acute stroke (within two weeks from the onset).
- Complete occlusion of the artery on the imaging assessment.
- Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
- Contraindications to antithrombotic and/or anticoagulant therapies.
About this study
Official title: Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)
Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients
Read the detailed description
Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted
- Conditions
- Stroke, Ischemic
- Being tested
- Intracranial Stenting by Intracranial Stent Device, Optimum 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.
Intracranial Stenting by Intracranial Stent DeviceDevice
Also called cardiac and wingspan IC stent device
Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted
Optimum medical treatmentDrug
Also called Clopidogrel 75 mg +Aspirin 161 mg
Optimum Medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Stenting | Other | 25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS Receives: Device: Intracranial Stenting by Intracranial Stent Device |
| Aspirin+Clopidogrel | Active comparator | 25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment Receives: Drug: Optimum medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of IC stented patients in comparison to medically treated
clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
Measured: 3 months
Functional improvement of IC stented patients in comparison to medically treated
Functional assessment by modified Rankin Scale (mRS) for functional improvement
Measured: 3 months
Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels
Measured: 3 months
Secondary outcomes (1)
No Recurrent Ischemic stroke in stented ICSD patients
Clinical Assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two armed medical study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Shafik Abdallah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393025
- Sponsor's protocol ID
- FMASU MD 142/2016
- Acronym
- VasIntervent
- Status last verified
- May 2020
- First submitted
- 16 Dec 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)
- ClinicalTrials.gov ID
- NCT04393025
- Acronym / sponsor ID
- VasIntervent / FMASU MD 142/2016
- Conditions
- Stroke, Ischemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 19 May 2020 (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.
Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients
Detailed description
Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two armed medical study
| Arm | Type | Receives |
|---|---|---|
| Intracranial Stenting | Other | Device: Intracranial Stenting by Intracranial Stent Device25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS |
| Aspirin+Clopidogrel | Active comparator | Drug: Optimum medical treatment25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age between 30-80 years.
- Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA).
- Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia).
Key exclusion criteria (5 listed)
- Patients previously stented at the target lesion or had extracranial stenosis.
- Patient with acute stroke (within two weeks from the onset).
- Complete occlusion of the artery on the imaging assessment.
- Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
- Contraindications to antithrombotic and/or anticoagulant therapies.
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 |
|---|---|---|
| Intracranial Stenting by Intracranial Stent DeviceAlso: cardiac and wingspan IC stent deviceLarge Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted | Device | Intracranial Stenting |
| Optimum medical treatmentAlso: Clopidogrel 75 mg +Aspirin 161 mgOptimum Medical treatment | Drug | Aspirin+Clopidogrel |
Primary outcome
Clinical improvement of IC stented patients in comparison to medically treated
Time frame: 3 months
clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
Functional improvement of IC stented patients in comparison to medically treated
Time frame: 3 months
Functional assessment by modified Rankin Scale (mRS) for functional improvement
Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
Time frame: 3 months
Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels
1 secondary outcome
No Recurrent Ischemic stroke in stented ICSD patients
Time frame: 6 months
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 19 May 2020.
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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 4 study testing Intracranial Stenting by Intracranial Stent Device and Optimum medical treatment in people with Stroke, Ischemic, run by Ain Shams 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 3 inclusion and 5 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 19 May 2020. 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 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?
Clinical improvement of IC stented patients in comparison to medically treated (time frame: 3 months). The study lists 3 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 19 May 2020.