Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)

Sponsor

Capital Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05909982

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. 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. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Reperfusion Injury	Procedure: Mechanical thrombectomy combined with ischemic post-conditioning	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ischemic post-conditioning group Mechanical thrombectomy combined with ischemic post-conditioning	Procedure: Mechanical thrombectomy combined with ischemic post-conditioning Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

Arm

Intervention/Treatment

Experimental: Ischemic post-conditioning group

Mechanical thrombectomy combined with ischemic post-conditioning

Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

Outcome Measures

Primary Outcome Measures

Infarct volume [72 hours after procedure]
Infarct volume at 72 hours after procedure

Secondary Outcome Measures

The progression of infarct volume [Baseline and 72 hours after procedure]
Difference of infarct volume between baseline and 72 hours after procedure
The proportion of functional independence at 90 days [90 days after procedure]
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 at 90 days [90 days after procedure]
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 at 90 days [90 days after procedure]
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 [24 hours after procedure]
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 [24 hours after procedure]
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 [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 [24 hours after procedure]
Recanalization rate at 24 hours after procedure (mTICI ≥2b)
Hemodynamic assessment [Within 24 hours after procedure]
Hemodynamic assessment within 24 hours after procedure

Other Outcome Measures

Safety outcome (mortality at 90 days) [90 days after procedure]
90-day mortality
Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) [Within 24 hours after procedure]
The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure
Safety outcome (the proportion of intracranial hemorrhage within 24 hours) [Within 24 hours after procedure]
The proportion of intracranial hemorrhage within 24 hours after procedure
Safety outcome (the proportion of malignant brain edema within 24 hours) [Within 24 hours after procedure]
The proportion of malignant brain edema within 24 hours after procedure
Procedure-related complications [During the procedure]
Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.