Clinical trial for Acute Ischemic Stroke
Official title Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
ClinicalTrials.gov ID: NCT05789823
What this study is testing
- What it's testing
- Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
- Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- Patients with contraindications to MRI;
See the full eligibility 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;
- Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
- Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
- Written informed consent provided by the patients or their legal relatives.
- Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
- Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- Patients with contraindications to MRI;
- Other conditions that the investigator considered inappropriate for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.