Skip to content

Application of Controllable catheter sheath in acute stroke thrombectomy: a prospective, multicenter real-world clinical study

Application of Controllable catheter sheath in acute stroke thrombectomy: a prospective, multicenter real-world clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121800
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

?Acute large vessel occlusion Stroke

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-85 years with acute ischemic stroke, NIHSS score =6, and confirmed intracranial major artery occlusion by imaging. 2. CT exclusion of intracranial hemorrhage. 3. Timely and effective completion of preoperative CTA assessment above the aortic arch. 4. For anterior circulation large vessel occlusion with ASPECTS score of 3 or higher, and basilar artery occlusion with pc-ASPECTS score of 6 or higher, within 24 hours after symptom onset. 5. Patients scheduled to undergo mechanical thrombectomy. 6. Complete and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known pregnancy or lactation. 2. Known severe allergy to contrast agents. 3. Any known history of cerebral hemorrhage. 4. Any known congenital coagulation disorder. 5. Known bleeding diathesis, coagulation factor deficiency, or oral anticoagulation with INR >3.0. 6. Known baseline platelet count 400 mg/dL. 8. Severe persistent hypertension with SBP > 200 and/or DBP > 120. 9. Renal failure with serum creatinine > 3.0 mg/dL or estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m². 10. Suspected septic thrombosis, active systemic infection, or suspected bacterial endocarditis. 11.? Patients with severe bilateral femoral artery or aortic lesions rendering them unsuitable for transfemoral thrombectomy. 12. Evidence of vascular imaging or suspicion of aortic dissection, or known connective tissue diseases affecting arteries (e.g., Marfan syndrome, Ehlers-Danlos syndrome). 13. Incomplete or invalid preoperative CTA acquisition data. 14. Patients whose symptoms spontaneously resolved after enrollment. 15. Known to be participating in another study involving a device or drug.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;Surgical access failure rate;The 90-day clinical outcome of the patients was assessed using the modified Rankin Scale (mRS) score.;Surgical approach time;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS) score;Incidence of CT PH2-type hemorrhagic transformation (defined according to the Heidelberg classification);CT ASPECTS score;Barthel Index;Target vessel re-occlusion rate;

Countries

China

Contacts

Public ContactZhang Yingying

Zhongshan Hospital, Fudan University

zhang.yingying@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026