Stroke, Acute Cerebral InfarctionPESETNCT03502408
Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy
A study testing Endovascular Thrombectomy in people with Stroke, Acute Cerebral Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Cerebral Infarction
- What is being tested?
- Endovascular Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Aug 2026
- Phase
- Interventional
- 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
- Clinical Inclusion Criteria:
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hours after time last know well
- No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 )
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- Patient/Legally Authorized Representative has signed the Informed Consent form
- Imaging Inclusion Criteria:
- ICA or MCA-M1 or MCA-M2 or BA occlusion (carotid occlusions can be cervical or intracranial with or without tandem MCA lesions) as evidenced by MRA or 4D-CTA
- Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is >/= 1.2 )
Who cannot join
- Clinical Exclusion Criteria:
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pregnant
- Known serious sensitivity to radiographic contrast agents
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- Treated with rtPA >6 hours after time last known well
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min).
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Current participation in another investigational drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- Neuroimaging Exclusion Criteria:
- ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria)
- Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
- Significant mass effect with midline shift
- Evidence of internal carotid artery dissection
- Intracranial stent implanted in the same vascular territory, known history of arterial tortuosity, and/or other arterial disease that precludes the safe deployment/removal of the thrombectomy device
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
MIN LOU, Ph.D., 8657187784811, loumingxc@vip.sina.com
MIN LOU, Ph.D.
About this study
This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.
Read the detailed description
Study design is a prospective, single-center study of acute ischemic stroke patients with large artery occlusion in 6-24 hours of stroke onset. According to patients or their family members' willing, patients who meet the inclusion criteria will be assigned to endovascular thrombectomy group with approved devices (only the devices listed in this protocol are approved for us) plus standard medical therapy or control group (standard medical therapy alone) after undergoing either CT Perfusion or MR Perfusion studies. Patients who have evidence of an ICA or MCA M1 or M2 or BA occlusion and a Target Mismatch Profile will be enrolled.
The intent of this study is to support thrombectomy beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms, with careful selection.
The study will enroll up to 55 patients. The primary endpoint, the modified Rankin Score, will be assessed at 3 months.
- Conditions
- Stroke, Acute Cerebral Infarction
- Being tested
- Endovascular Thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyProcedure or surgery
Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device
Endovascular ThrombectomyProcedure or surgery
Procedure:Endovascular Thrombectomy Device: Solitaire™ FR Revascularization Device
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Thrombectomy | Experimental | Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device Receives: Procedure: Endovascular Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good Functional Independence
This outcome will look at the proportion of patients with mRS 0-2 at day 90.
Measured: 90 days
Secondary outcomes (2)
Death
Death
Measured: 90 days
Symptomatic Intracranial Hemorrhage
Defined as NIHSS worsening of 4 or more points associated with ICH within 24 hours of randomization
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute Cerebral InfarctionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MIN LOU, Ph.D., Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502408
- Sponsor's protocol ID
- yan2017-150
- Acronym
- PESET
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT03502408
- Acronym / sponsor ID
- PESET / yan2017-150
- Conditions
- Stroke, Acute Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Apr 2018 (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 aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.
Detailed description
Study design is a prospective, single-center study of acute ischemic stroke patients with large artery occlusion in 6-24 hours of stroke onset. According to patients or their family members' willing, patients who meet the inclusion criteria will be assigned to endovascular thrombectomy group with approved devices (only the devices listed in this protocol are approved for us) plus standard medical therapy or control group (standard medical therapy alone) after undergoing either CT Perfusion or MR Perfusion studies. Patients who have evidence of an ICA or MCA M1 or M2 or BA occlusion and a Target Mismatch Profile will be enrolled.
The intent of this study is to support thrombectomy beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms, with careful selection.
The study will enroll up to 55 patients. The primary endpoint, the modified Rankin Score, will be assessed at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Thrombectomy | Experimental | Procedure: Endovascular ThrombectomyProcedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hours after time last know well
- No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 )
Key exclusion criteria (18 listed)
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pregnant
- Known serious sensitivity to radiographic contrast agents
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 |
|---|---|---|
| Endovascular ThrombectomyProcedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device | Procedure or surgery | Endovascular Thrombectomy |
| Endovascular ThrombectomyProcedure:Endovascular Thrombectomy Device: Solitaire™ FR Revascularization Device | Procedure or surgery | Endovascular Thrombectomy |
Primary outcome
Good Functional Independence
Time frame: 90 days
This outcome will look at the proportion of patients with mRS 0-2 at day 90.
2 secondary outcomes
Death
Time frame: 90 days
Symptomatic Intracranial Hemorrhage
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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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.
MIN LOU, Ph.D. study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Thrombectomy in people with Stroke, Acute Cerebral Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 10 inclusion and 18 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 23 Nov 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MIN LOU, Ph.D. (8657187784811, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good Functional Independence (time frame: 90 days). 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 23 Nov 2022.