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A Pilot Study of Combined Mechanical Thrombectomy and Selective Endovascular Hypothermia Therapy in Acute Ischemic Stroke Patients with Large Ischemic Core.

A Pilot Study of Combined Mechanical Thrombectomy and Selective Endovascular Hypothermia Therapy in Acute Ischemic Stroke Patients with Large Ischemic Core.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038972
Enrollment
Unknown
Registered
2020-10-11
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Acute ischemic stroke

Interventions

Thrombectomy and Hypothermia:Thrombectomy and Hypothermia

Sponsors

PLA Army Characteristic Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute ischemic stroke involving ICA and M1, aged >= 18 and = 15 and dominant hemisphere >= 20 at admission. 4. Patients with ncct-aspects score of 3-5 and meeting the following evaluation criteria at the same time: (1) Core infarct volume (rCBF decreased to less than 30% of the contralateral) >= 50ml and = 15ml [(Tmax >= 6S volume) - (core infarct volume)]; (3) Ischemic area (Tmax >= 6S) volume / core infarct volume >= 1.5; 5. For patients whose time from onset to puncture is less than 12 hours, the time from imaging to puncture is less than 1.5 hours, and the time from puncture to tici2b3 is less than 1 hour; 6. The patients with good vascular path can meet the needs of subsequent hypothermia treatment; 7. The patient or the legal representative of the patient voluntarily signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with clinical signs of brain hernia, such as unilateral or bilateral pupil dilation, fixation, light reflex and other brainstem reflex disappeared. 2. Patients with severe renal disease history (such as dialysis), or EGFR 70%, those with postoperative stenosis not relieved are expected. 9. Patients with severe trauma and operation history within 3 months. 10. Patients with complete atrioventricular block. 11. According to the New York Heart Association (NYHA) heart function classification, patients with heart function rating above grade II and previous history of congestive heart failure (CHF). 12. Patients with current drug or alcohol problems or experiences. 13. Patients who participated in the study were not considered suitable.

Design outcomes

Primary

MeasureTime frame
Symptomatic intracranial hemorrhage;the incidence of midline structure shift more than 5 mm within 48 hours of onset with unilateral or bilateral mydriasis and fixation;

Secondary

MeasureTime frame
NIHSS??;GCS;FOUR score;midline structure shift;intracranial pressure;mRs;

Countries

China

Contacts

Public ContactLi Wei

PLA Army characteristic medical center

1499793049@qq.com+86 13527371357

Outcome results

None listed

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