Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

NCT05592054 | Terminated DMC

• 1 other identifier: PROTECT-MT
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  defined as modified Rankin Scale (mRS) score shift

  90 days

Secondary Outcomes (11)

• Dichotomized mRS

  90 days

• Change in stroke severity

  24 hours post treatment

• Change in stroke severity

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

• Final infarct volume

  5-7 days post treatment

• Technical success rate

  24 hours after mechanical thrombectomy

Other Outcomes (4)

• Death

  90 days

• Intracerebral hemorrhage (ICH)

  7 days post treatment or discharge (whichever occurs first)

• SAE

  90 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Balloon guide catheters (BGCs)

Procedure: Balloon guide catheters (BGCs)

Control group

ACTIVE COMPARATOR

Standard guide catheter

Procedure: Standard guide catheter

Interventions

Balloon guide catheters (BGCs) PROCEDURE

MT procedure with Balloon guide catheters (BGCs)

Intervention group

Standard guide catheter PROCEDURE

MT procedure with standard guide catheter

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Jianimin Liu

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 39579782 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Officials

• Jianmin Liu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cerebrovascular Disease Center

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: February 7, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. 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. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. 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. 4. 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. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Locations

CN (1)