Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

Acute Ischemic Stroke Clinical Trial

— PROTECT-MT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05592054
• Other study ID #: PROTECT-MT
• Status: Suspended
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 of 0-2) in patients with acute ischemic stroke due to anterior circulation large vessel occlusion.

Primary Endpoints

Functional outcome, defined as modified Rankin Scale (mRS) score of 0-2, at 90 days (±14 days) .

Secondary Endpoints

1. Dichotomized mRS at 90 days after the operation (0-1 versus 2-6, 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1074
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. Acute ischemic stroke, caused by a large vessel occlusion of the anterior circulation cerebral artery confirmed on brain imaging (intracranial carotid artery or middle M1/proximal M2)

3. Femoral artery puncture can be finished within 24 hours of symptom onset based on local practice

4. Pre-event modified Rankin Scale score 0-1

5. Written informed consent obtained (by patient or appropriate proxy, according to local requirements)

Exclusion Criteria:

1. Intracranial hemorrhage on imaging

2. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory

3. Excessive vascular access tortuosity that navigating BGCs would be impossible

4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device

5. Any other condition precludes performing MT procedure

6. Occlusions in multiple vascular territories confirmed on CTA/MRA

7. Pregnancy

8. Allergy to contrast agents

9. Patients refuse to cooperate or unable to tolerate interventional operation

10. Expected lifetime<90 days

11. Unlikely to participate in follow-up assessments

12. Any other condition that, in the opinion of the investigator, not suitable for BGCs

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Large Vessel Occlusion
• Thrombectomy
• Thrombosis

Intervention

Procedure:
• Balloon guide catheters (BGCs)
MT procedure with Balloon guide catheters (BGCs)
• Standard guide catheter
MT procedure with standard guide catheter

Locations

Country	Name	City	State
China	Jianimin Liu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Deaths at 90 days (±14 days) post treatment	90 days
Other	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)
Other	SAE	Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee	90 days
Other	perioperative complications	Any perioperative complications such as bleeding transformation, cerebral edema, vascular re occlusion, vascular dissection, new watershed embolism, contrast agent extravasation, puncture site hematoma, vascular spasm, vascular rupture, perforating branch tear, vascular perforation, stress ulcer, contrast agent hypersensitivity, contrast agent nephropathy, etc.	Perioperative period
Primary	Functional outcome	defined as modified Rankin Scale (mRS)	90 days
Secondary	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
Secondary	Change in stroke severity	NIHSS	24 hours post treatment
Secondary	Change in stroke severity	NIHSS	7 days post treatment or discharge (whichever occurs first).
Secondary	Technical success rate	defined as successfully navigating the guide catheter into target vessel, and finishing the MT procedure without changing another guide catheter	24 hours after MT
Secondary	Reperfusion outcome	(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram.	24 hours after MT
Secondary	Reperfusion result	(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass	24 hours after MT
Secondary	Time from groin puncture to successful reperfusion	( eTICI 2c or greater)	24 hours after MT
Secondary	Revascularization quality	(eTICI 2c or greater) within 45 min of access	24 hours after MT
Secondary	Thrombectomy attempt (final)	Number of MT (final)	24 hours after MT
Secondary	Occurrence of emboli to a new territory	Occurrence of emboli to a new territory	90 days
Secondary	Final infarct volume	Final infarct volume at 5-7 days	5-7 days after MT