Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy (PROTECT-MT)

PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)

A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.

Study Overview

• Status: Terminated
• Conditions: Thrombosis; Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy
• Intervention / Treatment: Procedure: Balloon guide catheters (BGCs); Procedure: Standard guide catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 329
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Jianimin Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Balloon guide catheters (BGCs)	Procedure: Balloon guide catheters (BGCs); MT procedure with Balloon guide catheters (BGCs)
Active Comparator: Control group; Standard guide catheter	Procedure: Standard guide catheter; MT procedure with standard guide catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	defined as modified Rankin Scale (mRS) score shift	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stroke severity	NIHSS	24 hours post treatment
Change in stroke severity	NIHSS	7 days post treatment or discharge (whichever occurs first).
Dichotomized mRS	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)	90 days
Final infarct volume	Final infarct volume at 5-7 days post treatment	5-7 days post treatment
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	24 hours after mechanical thrombectomy
Reperfusion outcome	(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram.	24 hours after mechanical thrombectomy
Reperfusion outcome	(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass	24 hours after mechanical thrombectomy
Time from groin puncture to successful reperfusion	eTICI 2b or greater, eTICI 2c or greater	24 hours after mechanical thrombectomy
Revascularization quality	Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access	24 hours after mechanical thrombectomy
Thrombectomy attempt (final)	Number of thrombectomy attempts (final)	24 hours after mechanical thrombectomy
Occurrence of emboli to a new territory	Occurrence of emboli to a new territory	24 hours after mechanical thrombectomy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Deaths at 90 days (±14 days) post treatment	90 days
Intracerebral hemorrhage (ICH)	Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first)	7 days post treatment or discharge (whichever occurs first)
SAE	Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee	90 days
perioperative complications	Any peri-procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.	Perioperative period

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jianmin Liu, M.D., Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Stroke; Ischemic Stroke; Thrombosis
• Other Study ID Numbers: PROTECT-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.; Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No