Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy (NCT05592054) | Clinical Trial Compass
TerminatedNot Applicable
Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy
Stopped: DSMB suggestion
China329 participantsStarted 2023-02-07
Plain-language summary
A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)