NCT05592054

Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Balloon guide catheters (BGCs)	MT procedure with Balloon guide catheters (BGCs)
PROCEDURE	Standard guide catheter	MT procedure with standard guide catheter

Timeline

• Start date: 2023-02-07
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2022-10-24
• Last updated: 2024-07-16

Locations

1 site across 1 country: China