NCT05909982CompletedPhase 1/2
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)
Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 9 Jun 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 15 Oct 2023
- Lead sponsor
- Capital Medical University
- Diseases
- Stroke
- NCT number
- NCT05909982
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 1 Apr 2023 to the primary completion date, 15 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
Other illness
- Other conditions that the investigator considered inappropriate for inclusion.
Other
- 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;
- Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
- Patients with contraindications to MRI;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Huanhu Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.