Acute Ischemic StrokePROTECT-MTNCT05592054
Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy
A study testing Balloon guide catheters (BGCs) and Standard guide catheter in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Changhai Hospital at 1 site in China.
Trial summary
A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
- What is being tested?
- Balloon guide catheters (BGCs) and Standard guide catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2023to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- 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
- To receive MT within 24 hours after AIS onset according to local guidelines
- Preoperative mRS score of 0-1
- Signed informed consent form obtained from the subject (or approved surrogate)
Who cannot join
- Intracranial hemorrhage confirmed by imaging
- Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
- Excessive vascular access tortuosity disables the use of balloon guide catheter
- Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device
- Any other condition that precludes the performing of mechanical thrombectomy procedure
- Occlusions in multiple vascular territories confirmed by Computed Tomography Angiography(CTA) or Magnetic Resonance Angiography(MRA)
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- Subjects who are pregnant
- Subjects who are allergy to the contrast agent
- Subjects who refuse to cooperate or unable to tolerate interventional operation
- Subjects whose expected lifetime are less than 90 days
- Subjects who are unlikely to participate in follow-up assessments according to the investigator's judgement
- Any other condition that, according to the investigator's judgement, not suitable for using of balloon guide catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- 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).
- Change in stroke severity (NIHSS score) at 24 hours post treatment.
- Change in stroke severity (NIHSS score) at 7 days post treatment or discharge (whichever occurs first).
- Final infarct volume at 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).
- Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram.
- Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass.
- Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater).
- Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access.
- Number of thrombectomy attempts (final).
- Occurrence of emboli to a new territory.
Safety Endpoints:
- Deaths at 90 days (±14 days) post treatment.
- Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first).
- Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee.
- Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.
- Being tested
- Balloon guide catheters (BGCs), Standard guide catheter
- Medical subject headings
- Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon guide catheters (BGCs)Procedure or surgery
MT procedure with Balloon guide catheters (BGCs)
Standard guide catheterProcedure or surgery
MT procedure with standard guide catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Balloon guide catheters (BGCs) Receives: Procedure: Balloon guide catheters (BGCs) |
| Control group | Active comparator | Standard guide catheter Receives: Procedure: Standard guide catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
defined as modified Rankin Scale (mRS) score shift
Measured: 90 days
Secondary outcomes (11)
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)
Measured: 90 days
Change in stroke severity
NIHSS
Measured: 24 hours post treatment
Change in stroke severity
NIHSS
Measured: 7 days post treatment or discharge (whichever occurs first).
Final infarct volume
Final infarct volume at 5-7 days post treatment
Measured: 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
Measured: 24 hours after mechanical thrombectomy
Reperfusion outcome
(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram.
Measured: 24 hours after mechanical thrombectomy
Reperfusion outcome
(eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass
Measured: 24 hours after mechanical thrombectomy
Time from groin puncture to successful reperfusion
eTICI 2b or greater, eTICI 2c or greater
Measured: 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
Measured: 24 hours after mechanical thrombectomy
Thrombectomy attempt (final)
Number of thrombectomy attempts (final)
Measured: 24 hours after mechanical thrombectomy
Occurrence of emboli to a new territory
Occurrence of emboli to a new territory
Measured: 24 hours after mechanical thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start7 Feb 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: DSMB suggestion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-min Liu, Changhai Hospital
- Investigators
- Jianmin Liu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592054
- Sponsor's protocol ID
- PROTECT-MT
- Acronym
- PROTECT-MT
- Status last verified
- Jul 2024
- First submitted
- 20 Oct 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 42760130Liu 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 at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)
- ClinicalTrials.gov ID
- NCT05592054
- Acronym / sponsor ID
- PROTECT-MT / PROTECT-MT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB suggestion
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- Change in stroke severity (NIHSS score) at 24 hours post treatment.
- Change in stroke severity (NIHSS score) at 7 days post treatment or discharge (whichever occurs first).
- Final infarct volume at 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).
- Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram.
- Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass.
- Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater).
- Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access.
- Number of thrombectomy attempts (final).
- Occurrence of emboli to a new territory.
Safety Endpoints:
- Deaths at 90 days (±14 days) post treatment.
- Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first).
- Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee.
- Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Balloon guide catheters (BGCs)Balloon guide catheters (BGCs) |
| Control group | Active comparator | Procedure: Standard guide catheterStandard guide catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- 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
- To receive MT within 24 hours after AIS onset according to local guidelines
- Preoperative mRS score of 0-1
- Signed informed consent form obtained from the subject (or approved surrogate)
Key exclusion criteria (12 listed)
- Intracranial hemorrhage confirmed by imaging
- Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
- Excessive vascular access tortuosity disables the use of balloon guide catheter
- Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device
- Any other condition that precludes the performing of mechanical thrombectomy procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon guide catheters (BGCs)MT procedure with Balloon guide catheters (BGCs) | Procedure or surgery | Intervention group |
| Standard guide catheterMT procedure with standard guide catheter | Procedure or surgery | Control group |
Primary outcome
Functional outcome
Time frame: 90 days
defined as modified Rankin Scale (mRS) score shift
11 secondary outcomes
Dichotomized mRS
Time frame: 90 days
Change in stroke severity
Time frame: 24 hours post treatment
Change in stroke severity
Time frame: 7 days post treatment or discharge (whichever occurs first).
Final infarct volume
Time frame: 5-7 days post treatment
Technical success rate
Time frame: 24 hours after mechanical thrombectomy
Reperfusion outcome
Time frame: 24 hours after mechanical thrombectomy
Reperfusion outcome
Time frame: 24 hours after mechanical thrombectomy
Time from groin puncture to successful reperfusion
Time frame: 24 hours after mechanical thrombectomy
Revascularization quality
Time frame: 24 hours after mechanical thrombectomy
Thrombectomy attempt (final)
Time frame: 24 hours after mechanical thrombectomy
Occurrence of emboli to a new territory
Time frame: 24 hours after mechanical thrombectomy
Results and safety
The study was stopped early (reason given: DSMB suggestion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 42760130Chen 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.
- Derived from this study: PubMed 39579782Liu 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Liu, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon guide catheters (BGCs) and Standard guide catheter in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DSMB suggestion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.