CompletedNot Applicable

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

China203 participantsStarted 2024-01-17

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 years to 80 years.
✓. 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.
✓. Modified Rankin Scale (mRS) ≤ 2.
✓. 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.
✓. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

✕. Target aneurysm is an aneurysm requiring staged procedure.
✕. Target aneurysm that has been previously treated with vascular embolization or surgery.
✕. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
✕. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
✕. Acutely ruptured aneurysm within 14 days of enrollment.
✕. Hunt and Hess (H\&H) scale ≥3.
✕. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
✕. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.

Success aneurysm occlusion at 6 month post procedure

Timeframe: 6 months post procedure

NCT IDNCT06303063

SponsorSinomed Neurovita Technology Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-20

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 years to 80 years.
✓. 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.
✓. Modified Rankin Scale (mRS) ≤ 2.
✓. 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.
✓. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

✕. Target aneurysm is an aneurysm requiring staged procedure.
✕. Target aneurysm that has been previously treated with vascular embolization or surgery.
✕. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
✕. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
✕. Acutely ruptured aneurysm within 14 days of enrollment.
✕. Hunt and Hess (H\&H) scale ≥3.
✕. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
✕. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.