CompletedPhase 1/2

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

China20 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infarct volume

Timeframe: 72 hours after procedure

Trial details

NCT IDNCT05909982

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-15

View on ClinicalTrials.gov More Acute Ischemic Stroke trials