Skip to content

Penumbral rescue by low intensity pulsed ultrasound (LIPUS) in patients with ischemic stroke: Exploratory clinical trial

Penumbral rescue by low intensity pulsed ultrasound (LIPUS) in patients with ischemic stroke: Exploratory clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110472
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-79 years old 2. Meet the diagnosis of acute ischemic stroke; 3. mRS 0-1 points before the onset of the disease; 4. Baseline NIHSS score >=6 points; 5. Have a clear onset time and within 12 hours; 6. Preoperative multimodal CT imaging examination, including head CT plain scan, head CTP and head CTA; 7. Imaging criteria: CTP: 0ml15ml, mismatch rate >1.8; CTA: The blood vessel responsible for symptoms is proximal occlusion of the middle cerebral artery M1 and suggests embolic lesion (defined as the M1 segment is bounded by the origination site of the striated artery and occluded proximally); 8. Baseline infarct growth rate (IGR1) = 5ml/h (IGR1=baseline CTP core (ml)/onset to baseline CTP time (ml/h); 9. Ultrasound stimulation can be started within 15 minutes after imaging examination; 10. Planned endovascular treatment and eTICI grade 2c or 3 recanalization; 11. Patients or their families sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Intravenous thrombolysis of drugs; 2. Imaging suggests in situ chronic stenosis or extracranial stenosis tandem lesions; 3. History of cerebral infarction and TIA within 3 months; 4. Previous history of cerebral hemorrhage, brain tumor, or cerebrovascular malformation; 5. Presence of life-threatening diseases within 6 months that cannot be evaluated for 3 months; 6. Pregnant women, mental illness, severe liver and kidney insufficiency, severe heart failure; 7. Concurrent participation in another clinical drug or device intervention study; 8. Other situations that the investigator considers unsuitable for participating in this study;

Design outcomes

Primary

MeasureTime frame
Post-intervention infarct growth rate;Infarct growth volume;

Secondary

MeasureTime frame
NIHSS score;mRS score;

Countries

China

Contacts

Public ContactZheng Yuanyi

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

zhengyuanyi@163.com+86 189 3017 7162

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026