Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Thrombosis
Conditions
Brief summary
A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.
Detailed description
The PROTECT-MT study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation (PROBE) trial, and aims to determine the effectiveness of balloon guide catheter(BGC) as compared to standard guide catheter on functional outcome (modified Rankin Scale \[mRS\] score at Day 90) in patients with acute ischemic stroke due to anterior circulation large vessel occlusion. Primary Endpoints Functional outcome, defined as modified Rankin Scale (mRS) score, at 90 days (±14 days) . Secondary Endpoints 1. Dichotomized mRS at 90 days after the operation (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6, 0-4 versus 5-6, 0-5 versus 6). 2. Change in stroke severity (NIHSS score) at 24 hours post treatment. 3. Change in stroke severity (NIHSS score) at 7 days post treatment or discharge (whichever occurs first). 4. Final infarct volume at 5-7 days post treatment 5. Technical success rate (defined as successfully navigating the guide catheter into the target vessel, and finishing the mechanical thrombectomy procedure without changing to another guide catheter). 6. Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram. 7. Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass. 8. Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater). 9. Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access. 10. Number of thrombectomy attempts (final). 11. Occurrence of emboli to a new territory. Safety Endpoints: 1. Deaths at 90 days (±14 days) post treatment. 2. Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first). 3. Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee. 4. Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.
Interventions
PROCEDUREBalloon guide catheters (BGCs)
MT procedure with Balloon guide catheters (BGCs)
PROCEDUREStandard guide catheter
MT procedure with standard guide catheter
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Diagnosis of AIS with confirmed anterior circulation LVO (including intracranial segment of the internal carotid artery, and the first or proximal second segment \[M1 or proximal M2\] of the middle cerebral artery) by brain imaging 3. To receive MT within 24 hours after AIS onset according to local guidelines 4. Preoperative mRS score of 0-1 5. Signed informed consent form obtained from the subject (or approved surrogate)
Exclusion criteria
1. Intracranial hemorrhage confirmed by imaging 2. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 3. Excessive vascular access tortuosity disables the use of balloon guide catheter 4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device 5. Any other condition that precludes the performing of mechanical thrombectomy procedure 6. Occlusions in multiple vascular territories confirmed by Computed Tomography Angiography(CTA) or Magnetic Resonance Angiography(MRA) 7. Subjects who are pregnant 8. Subjects who are allergy to the contrast agent 9. Subjects who refuse to cooperate or unable to tolerate interventional operation 10. Subjects whose expected lifetime are less than 90 days 11. Subjects who are unlikely to participate in follow-up assessments according to the investigator's judgement 12. Any other condition that, according to the investigator's judgement, not suitable for using of balloon guide catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | 90 days | defined as modified Rankin Scale (mRS) score shift |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | 24 hours after mechanical thrombectomy | defined as successfully navigating the guide catheter into the target vessel, and finishing the mechanical thrombectomy procedure without changing to another guide catheter |
| Time from groin puncture to successful reperfusion | 24 hours after mechanical thrombectomy | eTICI 2b or greater, eTICI 2c or greater |
| Revascularization quality | 24 hours after mechanical thrombectomy | Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access |
| Thrombectomy attempt (final) | 24 hours after mechanical thrombectomy | Number of thrombectomy attempts (final) |
| Occurrence of emboli to a new territory | 24 hours after mechanical thrombectomy | Occurrence of emboli to a new territory |
| Dichotomized mRS | 90 days | Dichotomized mRS (0-1 versus 2-6,0-2 versus 3-6,0-3 versus 4-6,0-4 versus 5-6,0-5 versus 6) |
| Change in stroke severity | 24 hours post treatment | NIHSS |
| Final infarct volume | 5-7 days post treatment | Final infarct volume at 5-7 days post treatment |
| Reperfusion outcome | 24 hours after mechanical thrombectomy | (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAE | 90 days | Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee |
| perioperative complications | Perioperative period | Any peri-procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc. |
| Intracerebral hemorrhage (ICH) | 7 days post treatment or discharge (whichever occurs first) | Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first) |
| Death | 90 days | Deaths at 90 days (±14 days) post treatment |
Countries
China
Outcome results
None listed