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

Capital Medical University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Ischemic Stroke

Reperfusion Injury

Treatments

Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT05909982

PROTECT-1b

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.