Clinical trial NCT05592054: Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy
Official title: PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Large Vessel Occlusion
Thrombectomy
Thrombosis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome
timeFrame: 90 days
Secondary outcomes:
measure: Dichotomized mRS
timeFrame: 90 days
measure: Change in stroke severity
timeFrame: 24 hours post treatment
measure: Change in stroke severity
timeFrame: 7 days post treatment or discharge (whichever occurs first).
measure: Final infarct volume
timeFrame: 5-7 days post treatment
measure: Technical success rate
timeFrame: 24 hours after mechanical thrombectomy
measure: Reperfusion outcome
timeFrame: 24 hours after mechanical thrombectomy
measure: Reperfusion outcome
timeFrame: 24 hours after mechanical thrombectomy
measure: Time from groin puncture to successful reperfusion
timeFrame: 24 hours after mechanical thrombectomy
measure: Revascularization quality
timeFrame: 24 hours after mechanical thrombectomy
measure: Thrombectomy attempt (final)
timeFrame: 24 hours after mechanical thrombectomy
measure: Occurrence of emboli to a new territory
timeFrame: 24 hours after mechanical thrombectomy
Other outcomes:
measure: Death
timeFrame: 90 days
measure: Intracerebral hemorrhage (ICH)
timeFrame: 7 days post treatment or discharge (whichever occurs first)
measure: SAE
timeFrame: 90 days
measure: perioperative complications
timeFrame: Perioperative period
Locations:
city: Shanghai
country: China
facility: Jianimin Liu
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: