Clinical trial NCT06303063: Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms
Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: wide-necked cerebral aneurysms
Brain Aneurysm
Cerebral Aneurysm
Stent
Lead sponsor: Sinomed Neurovita Technology Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

Detailed description: This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years to 80 years.
2. Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
3. Modified Rankin Scale (mRS) ≤ 2.
4. Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

Exclusion Criteria:

1. Target aneurysm is an aneurysm requiring staged procedure.
2. Target aneurysm that has been previously treated with vascular embolization or surgery.
3. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
4. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
5. Acutely ruptured aneurysm within 14 days of enrollment.
6. Hunt and Hess (H\&H) scale ≥3.
7. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
8. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
9. Platelet count \<50\*103/mm3 (50\*109/L) or any known coagulation deficiency, or International normalized ratio (INR)\>3.0.
10. Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
11. Life expectancy \< 1 year, and unable to complete the required follow-ups;
12. Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
13. Currently enrolled in another investigational device or drug study.

Primary outcomes:
measure: Success aneurysm occlusion at 6 month post procedure
timeFrame: 6 months post procedure
Secondary outcomes:
measure: Technical success
timeFrame: Intra-procedure
measure: Success aneurysm occlusion immediately after the procedure
timeFrame: Immediately after the procedure
measure: Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure
timeFrame: 6 months post procedure
measure: Complete aneurysm occlusion at 6 months post procedure
timeFrame: 6 months post procedure
measure: Retreatment Rate at 6 months and 1 year post procedure
timeFrame: 6 months, 1 year post procedure
measure: In-Stent Stenosis at 6 months post procedure
timeFrame: 6 months post procedure
measure: Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure
timeFrame: 30 days, 6 months, 1 year post procedure
measure: Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure
timeFrame: 30 days, 6 months, 1 year post procedure
measure: All-cause mortality at 30 days, 6 months and 1 year post procedure
timeFrame: 30 days, 180 days and 1 year post procedure
measure: Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure
timeFrame: 30 days, 6 months and 1 year post procedure
measure: In-stent thrombosis at 6 months post procedure
timeFrame: 6 months post procedure
measure: Rate of Device defect
timeFrame: within 1 year of whole trial
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jianxin Yang
role: PRINCIPAL_INVESTIGATOR
References: