Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

NCT ID: NCT05592054

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-03-25

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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy; Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Balloon guide catheters (BGCs)

Group Type: EXPERIMENTAL

Balloon guide catheters (BGCs)

Intervention Type: PROCEDURE

MT procedure with Balloon guide catheters (BGCs)

Control group

Standard guide catheter

Group Type: ACTIVE_COMPARATOR

Standard guide catheter

Intervention Type: PROCEDURE

MT procedure with standard guide catheter

Interventions

Balloon guide catheters (BGCs)

MT procedure with Balloon guide catheters (BGCs)

Intervention Type: PROCEDURE

Standard guide catheter

MT procedure with standard guide catheter

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian-min Liu

Director of Cerebrovascular Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Jianimin Liu

Shanghai, , China

Countries

China

References

Liu J, Zhou Y, Zhang L, Li Z, Chen W, Zhu Y, Yao X, Zhang L, Liu S, Peng Y, Wei M, Zhang Q, Shu H, Wang S, Liu W, Wan S, Li T, Fang Y, Han H, Zhang G, Huang L, Wang F, Cheng G, Gao L, Shi H, Han J, Luo Y, Li S, Cai C, Yin R, Jin Z, Shao C, Tian B, Zhang Y, Li Q, Zhang Y, Zhang P, Li B, Xing P, Shen H, Zhu X, Zhang X, Hua W, Shen F, Huyan M, Chen R, Zuo Q, Li Q, Huang Q, Xu Y, Deng B, Zhao R, Goyal M, Zhang Y, Yang P; PROTECT-MT Investigators. Balloon guide catheters for endovascular thrombectomy in patients with acute ischaemic stroke due to large-vessel occlusion in China (PROTECT-MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet. 2024 Nov 30;404(10468):2165-2174. doi: 10.1016/S0140-6736(24)02315-8. Epub 2024 Nov 20.

Reference Type: DERIVED

PMID: 39579782 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PROTECT-MT

Identifier Type: -

Identifier Source: org_study_id