Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy
Reason given: DSMB suggestion
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Trial details
- Who runs it
- Changhai Hospital
- Trial code
- NCT05592054
- Record updated
- 16 July 2024
- Original description
A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Intracranial hemorrhage confirmed by imaging; Any other condition that precludes the performing of mechanical thrombectomy procedure; Subjects who are allergy to the contrast agent; Any other condition that, according to the investigator's judgement, not suitable for using of balloon guide catheter; 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; Occlusions in multiple vascular territories confirmed by Computed Tomography Angiography(CTA) or Magnetic Resonance Angiography(MRA); Subjects who are pregnant; 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.