PROTECT: Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

Sponsor

Capital Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153655

Collaborator

(none)

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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 purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Procedure: Local ischemic post-conditioning	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ischemic post-conditioning group The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.	Procedure: Local ischemic post-conditioning Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.

Arm

Intervention/Treatment

Experimental: Ischemic post-conditioning group

The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.

Procedure: Local ischemic post-conditioning

Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.

Outcome Measures

Primary Outcome Measures

Number of participants with major response [Immediately after intervention on the day of ischemic post-conditioning]
Major response is any of the following: Vessel perforation or rupture; Reocclusion of the culprit vessel after post-conditioning; Vessel dissection; Severe vasospasm; Ischemic post-conditioning related thrombotic events; Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 years;
Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.