NCT06967025CompletedPhase 2
Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy
Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy: Mechanistic Exploration Through a Randomized Controlled Pilot Trial
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
This clinical trial will evaluate whether on-site ischemic postconditioning (IPostC) improves outcomes in acute stroke patients receiving endovascular thrombectomy (EVT) and explore its mechanisms. The investigators aim to answer: (1) Is on-site IPostC effective compared to EVT alone? (2) What molecular markers and cellular pathways does on-site IPostC influence? Participants will be randomized to EVT alone or EVT+IPostC (4 cycles of 2-minute balloon occlusion/reperfusion). The investigators will assess infarct size, functional outcomes, biomarkers (e.g., multi-omics, ELISA, and clinical laboratory parameters), and safety (e.g., mortality, procedure-related complications).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Apr 2025
- Start date
- 12 Sept 2024
- Primary completion date
- 15 Aug 2025
- Lead sponsor
- Tianjin Huanhu Hospital
- Diseases
- Stroke
- NCT number
- NCT06967025
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 12 Sept 2024 to the primary completion date, 15 Aug 2025
- 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
- The patient is currently enrolled in another investigational drug or device trial.
Other illness
- Adverse events related to thrombectomy, such as contrast extravasation, vascular rupture/perforation, dissection, or embolization to a new territory, detected on post-thrombectomy angiography.
- The patient is febrile (temperature \> 37.5 °C) or has experienced an infection with fever in the last 5 days.
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, Clopidogrel, tirofiban, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
- The patient has a pre-AIS life expectancy of \<1 year due to underlying medical conditions or pre-existing co-morbidities.
- The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy.
- Other conditions deemed unsuitable for inclusion by the investigator.
Lab values
- The patient has known history of Congestive Heart Failure, hepatic failure, end-stage kidney disease or severe renal failure (clearance \< 30ml/min/1.73m²).
Other
- The interventionalist deems the study device unable to reach the target site.
- Stent placement performed in the M1 segment of the middle cerebral artery or the terminal segment of the internal carotid artery during thrombectomy.
- Angioplasty of more than two cycles of balloon inflation/deflation.
- The patient is experiencing cardiogenic shock, systolic blood pressure \[SBP\] \<100 mmHg, HR\>100 bpm and arterial oxygen saturation (pulse oximetry) \<92% without additional oxygen.
- The patient is a female who is known to be pregnant.
Who the study is looking for
- The patient is ≥ 18 years of age.
- The patient must have symptoms consistent with AIS (i.e. face drooping, arm weakness, speech difficulty, etc.) , with symptoms severity of baseline NIHSS ≥ 6 and beginning less than 24 hours prior to presentation at hospital.
- Pre-stroke mRS ≤ 2.
- Baseline ASPECTS ≥ 6.
- Unilateral middle cerebral artery occlusion, and/or internal carotid artery occlusion.
- The patient is eligible for EVT.
- Successful recanalization achieved through EVT (eTICI 2b-3).
- The patient is willing to provide written informed consent to participate in this clinical trial.
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.