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Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

Sponsor
Changhai Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05592054
Collaborator
(none)
1,074
Enrollment
2
Arms
25.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Balloon guide catheters (BGCs)
  • Procedure: Standard guide catheter
 Phase 3

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 of 0-2) in patients with acute ischemic stroke due to anterior circulation large vessel occlusion.

Primary Endpoints

Functional outcome, defined as modified Rankin Scale (mRS) score of 0-2, at 90 days (±14 days) .

Secondary Endpoints

  1. Dichotomized mRS at 90 days after the operation (0-1 versus 2-6, 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. 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).

  5. Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram.

  6. Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass.

  7. Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater).

  8. Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access.

  9. Number of thrombectomy attempts (final).

  10. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1074 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)
Anticipated Study Start Date :
Nov 20, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Balloon guide catheters (BGCs)

Procedure: Balloon guide catheters (BGCs)
MT procedure with Balloon guide catheters (BGCs)
Active Comparator: Control group

Standard guide catheter

Procedure: Standard guide catheter
MT procedure with standard guide catheter

Outcome Measures

Primary Outcome Measures

  1. Functional outcome [90 days]

    defined as modified Rankin Scale (mRS) 0-2

Secondary Outcome Measures

  1. Dichotomized mRS [90 days]

    Dichotomized mRS (0-1 versus 2-6, 0-3 versus 4-6,0-4 versus 5-6,0-5 versus 6)

  2. Change in stroke severity [24 hours post treatment]

    NIHSS

  3. Change in stroke severity [7 days post treatment or discharge (whichever occurs first).]

    NIHSS

  4. Technical success rate [24 hours after MT]

    defined as successfully navigating the guide catheter into target vessel, and finishing the MT procedure without changing another guide catheter

  5. Reperfusion outcome [24 hours after MT]

    (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram.

  6. Reperfusion result [24 hours after MT]

    (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass

  7. Time from groin puncture to successful reperfusion [24 hours after MT]

    ( eTICI 2c or greater）

  8. Revascularization quality [24 hours after MT]

    (eTICI 2c or greater) within 45 min of access

  9. Thrombectomy attempt (final) [24 hours after MT]

  10. Occurrence of emboli to a new territory [90 days]

Other Outcome Measures

  1. Death [90 days]

  2. Intracerebral hemorrhage (ICH) [7 and 90 days]

    symptomatic ICH, asymptomatic ICH

  3. SAE [90 days]

  4. Procedure complication [24 hours after MT]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18 years or older

  2. Acute ischemic stroke, caused by a large vessel occlusion of the anterior circulation cerebral artery confirmed on brain imaging (intracranial carotid artery or middle M1/proximal M2)

  3. Femoral artery puncture can be finished within 24 hours of symptom onset based on local practice

  4. Pre-event modified Rankin Scale score 0-1

  5. Written informed consent obtained (by patient or appropriate proxy, according to local requirements)

Exclusion Criteria:

  1. Intracranial hemorrhage on imaging

  2. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory

  3. Excessive vascular access tortuosity that navigating BGCs would be impossible

  4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device

  5. Any other condition precludes performing MT procedure

  6. Occlusions in multiple vascular territories confirmed on CTA/MRA

  7. Pregnancy

  8. Allergy to contrast agents

  9. Patients refuse to cooperate or unable to tolerate interventional operation

  10. Expected lifetime<90 days

  11. Unlikely to participate in follow-up assessments

  12. Any other condition that, in the opinion of the investigator, not suitable for BGCs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Principal Investigator: Jianmin Liu, M.D., Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jian-min Liu, Director of Cerebrovascular Disease Center, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05592054
Other Study ID Numbers:
  • PROTECT-MT
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ischemic Stroke
Thrombosis

Study Results

No Results Posted as of Oct 24, 2022