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TerminatedNCT05592054PROTECT-MTUpdated Jul 16, 2024

Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

An interventional study of Balloon guide catheters (BGCs) and Standard guide catheter in Acute Ischemic Stroke, Large Vessel Occlusion and Thrombectomy, sponsored by Changhai Hospital. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
DSMB suggestion
Phase
Not applicable
Study type
Interventional
Enrollment
329
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Acute Ischemic Stroke
  • Large Vessel Occlusion
  • Thrombectomy
  • Thrombosis
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 329 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Browse Changhai Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
329 participants (actual)

Study arms

  • Experimental
    Intervention group

    Balloon guide catheters (BGCs)

    Procedure: Balloon guide catheters (BGCs)

  • Active comparator
    Control group

    Standard guide catheter

    Procedure: Standard guide catheter

Interventions

  • ProcedureBalloon guide catheters (BGCs)

    MT procedure with Balloon guide catheters (BGCs)

  • ProcedureStandard guide catheter

    MT procedure with standard guide catheter

06

What researchers measure

Primary outcomes

  1. Functional outcome

    defined as modified Rankin Scale (mRS) score shift

    Time frame: 90 days

Secondary outcomes

  1. 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)

    Time frame: 90 days

  2. Change in stroke severity

    NIHSS

    Time frame: 24 hours post treatment

  3. Change in stroke severity

    NIHSS

    Time frame: 7 days post treatment or discharge (whichever occurs first).

  4. Final infarct volume

    Final infarct volume at 5-7 days post treatment

    Time frame: 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

    Time frame: 24 hours after mechanical thrombectomy

  6. Reperfusion outcome

    (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram.

    Time frame: 24 hours after mechanical thrombectomy

  7. Reperfusion outcome

    (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass

    Time frame: 24 hours after mechanical thrombectomy

  8. Time from groin puncture to successful reperfusion

    eTICI 2b or greater, eTICI 2c or greater

    Time frame: 24 hours after mechanical thrombectomy

  9. Revascularization quality

    Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access

    Time frame: 24 hours after mechanical thrombectomy

  10. Thrombectomy attempt (final)

    Number of thrombectomy attempts (final)

    Time frame: 24 hours after mechanical thrombectomy

  11. Occurrence of emboli to a new territory

    Occurrence of emboli to a new territory

    Time frame: 24 hours after mechanical thrombectomy

Other outcomes

  1. Death

    Deaths at 90 days (±14 days) post treatment

    Time frame: 90 days

  2. Intracerebral hemorrhage (ICH)

    Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first)

    Time frame: 7 days post treatment or discharge (whichever occurs first)

  3. SAE

    Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee

    Time frame: 90 days

  4. perioperative complications

    Any peri-procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.

    Time frame: Perioperative period

07

Study locations

1 site
  • Jianimin Liu
    Shanghai, China
08

References and documents

Publications

  • Chen H, Yi T, Xing P, Lin DL, Lin XH, Chen Z, Zhou Y, Wu YM, Pan ZN, Zeng L, Wang S, Li T, Huang W, Yang YN, Ye JH, Cai Z, Liu J, Yang P, Chen WH; PROTECT-MT Investigators. Balloon guide catheter outcomes by occlusion site in the randomized PROTECT-MT trial. J Neurointerv Surg. 2026 Sep 18:jnis-2026-025857. doi: 10.1136/jnis-2026-025857. Online ahead of print. PubMed 42760130 ↗
  • 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. PubMed 39579782 ↗

Study documents

  • Study protocol · Oct 25, 2023
  • Statistical analysis plan · Jul 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data sharing will be available from 12 months after the publication of the main results.

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.

Data sharing details ↗ · www.ocin.org.cn

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in Mar 2024, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2022
First posted
Oct 24, 2022
StartActual
Feb 7, 2023
Primary completionActual
Mar 25, 2024
CompletionActual
Mar 25, 2024
Last update
Jul 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05592054
Lead sponsor
Changhai Hospital
Responsible party
Jian-min Liu (Director of Cerebrovascular Disease Center, Changhai Hospital) — Principal investigator
First posted
Oct 24, 2022
Start date
Feb 7, 2023
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Last update
Jul 16, 2024

Study contacts

Jianmin Liu, M.D.
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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