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Stent Implantation versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Clinical Trial

Stent Implantation versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Clinical Trial - START

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072009
Enrollment
Unknown
Registered
2023-05-31
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Acute Anterior Circulation Tandem Occlusion

Interventions

control group(non-stent implantation group in acute phase):Intracranial thrombectomy(internal carotid artery intracranial segment or the middle cerebral artery)successful recanalization(eTICI=2b_50)wi
Experimental group(stent implantation group in acute phase):Intracranial thrombectomy(internal carotid artery intracranial segment or the middle cerebral artery) successful recanalization(eTICI=2b_50

Sponsors

Lishui Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria for participants: 1. Age 18-85 years old; 2. Clinical diagnosis of acute ischemic stroke, the onset time within 24 hours; 3. Pre-stroke mRS score of 0-1; 4. NIHSS score of 6-30 before randomization; 5. Able to be randomized within 24 hours after stroke onset; 6. The patient or his or her legal representative has signed an informed consent form. Imaging inclusion criteria for subjects: 1. Proximal intracranial occlusion eligible for thrombectomy (intracranial ICA, M1, and/or M2 segment of the middle cerebral artery): (1)Develop symptoms within 6 hours (2)Develop symptoms within 6-16 hours and meet DAWN or DEFUSE-3 criteria (3)Develop symptoms within 16-24 hours and meet DAWN criteria (DSA imaging is preferred).* 2. Patients with tandem lesions on the ipsilateral extracranial segment of the carotid artery with stenosis =70% or occlusion; 3. ASPECT score =6 points on CT or MRI (DWI) 4. Continuous observation for 10 minutes or more, the ipsilateral extracranial segment of the carotid artery achieved a flow eTICI= 2b_50 after endovascular treatment.

Exclusion criteria

Exclusion criteria: General exclusion criteria for participants: 1. Participating in another clinical trial; 2. Planning elective carotid artery stenting within 3 months; 3. Intracranial hemorrhage or subarachnoid hemorrhage within 3 months; 4. Substantial organ surgery or biopsy within one month; 5. SBP > 185 mmHg or DBP > 110 mmHg; 6. Severe active bleeding or known bleeding diathesis; 7. Severe dysfunction of major organs such as the heart, liver, and kidney (glomerular filtration rate 220 µmol/L); 8. Undergoing percutaneous coronary intervention or cerebrovascular intervention surgery within 48 hours; 9. History of brain tumor with occupying effect or cerebral vasculitis; 10. Pre-existing neurological or psychiatric diseases that affect the evaluation in the study; 11. Pregnant or breastfeeding women; 12. Have a severe allergy to contrast agents; contraindication to imaging with contrast agents. 13. Expected survival time less than 1 year; 14. Unable to finish follow-up. Imaging exclusion criteria for participants: 1. Evidence of posterior circulation lesions after imaging confirmation; 2. Presence of midline shift or brain herniation, ventricular mass effect; 3. Newly developed bilateral acute cerebral infarction or intracranial multi-domain large vessel occlusion; 4. Difficult to perform endovascular treatment due to vascular variation; 5. Simultaneous ipsilateral internal carotid artery and anterior cerebral artery occlusion.

Design outcomes

Primary

MeasureTime frame
Rate of neurological functional independent (mRS=2).[at 90 (±7) days];The incidence of symptomatic intracranial hemorrhage at 48h after randomization. (according to the Heidelberg classification);

Countries

China

Contacts

Public ContactXueli Cai

Lishui Municipal Central Hospital

xueli_cai_official@126.com+86 139 6705 9836

Outcome results

None listed

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