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Clinical study on the reduction of reperfusion of brain tissue by blood flow control after mechanical thrombectomy

Clinical study on the reduction of reperfusion of brain tissue by blood flow control after mechanical thrombectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035659
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

large vessel occlusion - stroke

Interventions

Group 1:retained balloon catheter
Group 2:Not retained balloon catheter

Sponsors

Shanghai 6th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 85 years old; 2. Anterior circulation aortic occlusion is diagnosed by cerebrovascular imaging, the onset time is less than 8h, and patients is evaluated to undergo mechanical thrombectomy surgery; 3. ASPECTS = 6 points (non-enhanced CT), 0 <NIHSS score <30 points (on admission), mRS score <2 points (before the onset), develops clinical symptoms and signs of acute ischemic stroke; 4. Patient who can obtain 2b and 3 levels of recanalization after thrombectomy therapy; 5. The investigator believe that the patient is suitable for receiving an indwelling balloon catheter system to control blood flow and reduce ischemia-reperfusion injury; 6. Patients volunteered to conduct the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients whose life expectancy is less than 3 months; 2. Stroke is accompanied by epilepsy. Patient has a history of intracranial tumors, cerebral arteriovenous malformations, or aneurysms without treatment. Patient has cerebral infarction, myocardial infarction, pulmonary infarction, or uncontrolled severe in the past 3 months Infectious diseases (endocarditis or sepsis, etc.); 3. Patients with coagulation dysfunction or severe heart, liver, kidney dysfunction or systemic infection who are not suitable for interventional therapy; 4. Patients who exclude intracranial parenchymal hematoma by ordinary CT or cone beam CT immediately after operation 5. Patients who participated in clinical trials of other drugs or devices, and has not left the group or withdrawn within 1 month before the screening period of this trial; 6. Patients who have known contraindications to heparin, aspirin, clopidogrel, anesthesia, contrast agents or X-rays.

Design outcomes

Primary

MeasureTime frame
mRS;

Countries

China

Contacts

Public ContactZhu Yueqi

Shanghai 6th People's Hospital

zhuyueqi@hotmail.com+86 021-64368031

Outcome results

None listed

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