Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

Not Applicable

Terminated

• Conditions: Large Vessel Occlusion; Acute Ischemic Stroke; Thrombectomy; Thrombosis
• Interventions: Procedure: Balloon guide catheters (BGCs); Procedure: Standard guide catheter

• Registration Number: NCT05592054
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-24
• Study Start: 2023-02-07
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 329

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Balloon guide catheters (BGCs)	Balloon guide catheters (BGCs)
Control group	Standard guide catheter	Standard guide catheter

Primary Outcome Measures

Name	Time	Method
Functional outcome	90 days	defined as modified Rankin Scale (mRS) score shift

Secondary Outcome Measures

Name	Time	Method
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
Reperfusion outcome	24 hours after mechanical thrombectomy	(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass
Time from groin puncture to successful reperfusion	24 hours after mechanical thrombectomy	eTICI 2b or greater, eTICI 2c or greater
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)
Occurrence of emboli to a new territory	24 hours after mechanical thrombectomy	Occurrence of emboli to a new territory
Final infarct volume	5-7 days post treatment	Final infarct volume at 5-7 days post treatment
Change in stroke severity	7 days post treatment or discharge (whichever occurs first).	NIHSS
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)

Trial Locations

Locations (1)

Jianimin Liu; 🇨🇳 Shanghai, China