Back to resultsIschemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Primary Purpose
Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Mechanical thrombectomy combined with ischemic post-conditioning
Mechanical thrombectomy alone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; Previous mRS ≤ 2; Baseline NIHSS ≥ 6; Baseline ASPECTS ≥ 6; With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery; Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA; Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; > 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy; Patients with contraindications to MRI; Other conditions that the investigator considered inappropriate for inclusion.
Sites / Locations
- Tianjin Huanhu Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Ischemic post-conditioning group
Control group
Arm Description
Mechanical thrombectomy combined with ischemic post-conditioning
Mechanical thrombectomy alone
Outcomes
Primary Outcome Measures
Infarct volume
Infarct volume at 72 hours after procedure
Secondary Outcome Measures
The progression of infarct volume
Difference of infarct volume between baseline and 72 hours after procedure
The proportion of functional independence
The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
The proportion of favorable outcome
The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
The distribution of the mRS score
The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
National Institute of Health Stroke Scale (NIHSS) score
NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
The proportion of early neurological improvement
NIHSS 0-2 or ≥8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
NIHSS score at 7 days after procedure/discharge
NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Recanalization rate
Recanalization rate at 24 hours after procedure (mTICI ≥2b)
Full Information
NCT ID
NCT05789823
First Posted
March 16, 2023
Last Updated
March 28, 2023
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05789823
Brief Title
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Official Title
Efficacy and Safety of Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ischemic post-conditioning group
Arm Type
Experimental
Arm Description
Mechanical thrombectomy combined with ischemic post-conditioning
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Mechanical thrombectomy alone
Intervention Type
Procedure
Intervention Name(s)
Mechanical thrombectomy combined with ischemic post-conditioning
Intervention Description
Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 5 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
Intervention Type
Procedure
Intervention Name(s)
Mechanical thrombectomy alone
Intervention Description
Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.
Primary Outcome Measure Information:
Title
Infarct volume
Description
Infarct volume at 72 hours after procedure
Time Frame
72 hours after procedure
Secondary Outcome Measure Information:
Title
The progression of infarct volume
Description
Difference of infarct volume between baseline and 72 hours after procedure
Time Frame
Baseline and 72 hours after procedure
Title
The proportion of functional independence
Description
The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Time Frame
90 days after procedure
Title
The proportion of favorable outcome
Description
The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Time Frame
90 days after procedure
Title
The distribution of the mRS score
Description
The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Time Frame
90 days after procedure
Title
National Institute of Health Stroke Scale (NIHSS) score
Description
NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Time Frame
24 hours after procedure
Title
The proportion of early neurological improvement
Description
NIHSS 0-2 or ≥8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Time Frame
24 hours after procedure
Title
NIHSS score at 7 days after procedure/discharge
Description
NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Time Frame
7 days after procedure/discharge
Title
Recanalization rate
Description
Recanalization rate at 24 hours after procedure (mTICI ≥2b)
Time Frame
24 hours after procedure
Other Pre-specified Outcome Measures:
Title
Safety outcome (mortality at 90 days)
Description
90-day mortality
Time Frame
90 days after procedure
Title
Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)
Description
The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure
Time Frame
Within 24 hours after procedure
Title
Safety outcome (the proportion of intracranial hemorrhage within 24 hours)
Description
The proportion of intracranial hemorrhage within 24 hours after procedure
Time Frame
Within 24 hours after procedure
Title
Safety outcome (the proportion of malignant brain edema within 24 hours)
Description
The proportion of malignant brain edema within 24 hours after procedure
Time Frame
Within 24 hours after procedure
Title
Procedure-related complications
Description
Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years;
Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
Previous mRS ≤ 2;
Baseline NIHSS ≥ 6;
Baseline ASPECTS ≥ 6;
With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
Written informed consent provided by the patients or their legal relatives.
Exclusion Criteria:
Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
Patients with contraindications to MRI;
Other conditions that the investigator considered inappropriate for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD
Phone
010-83198952
Email
jixm@ccmu.edu.cn
Facility Information:
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming We, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
36523440
Citation
Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/36523440/
Description
Related Info
Learn more about this trial
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
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