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

Last updated: March 29, 2024
Sponsor: Sinomed Neurovita Technology Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

SINOMED IAS Stent System

Neuroform Atlas Stent System

Intracranial stent system

Clinical Study ID

NCT06303063
SNSC-IAS-202301
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ≥ 2.5mm and ≤ 5mm.
  3. Modified Rankin Scale (mRS) ≤ 2.
  4. Subject understands the nature of the procedure, provides voluntary written informedconsent prior to the treatment, and is willing to comply with specified follow-upevaluation.
  5. The investigators judged the use of stent-assisted coil embolization to be appropriatefor the treatment of intracranial aneurysm.

Exclusion

Exclusion Criteria:

  1. Target aneurysm is an aneurysm requiring staged procedure.
  2. Target aneurysm that has been previously treated with vascular embolization orsurgery.
  3. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, bloodblister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenousmalformations.
  4. Hospitalized surgical treatment within 30 days before operation, or plannedhospitalized 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 thatmake it difficult to reach the site of the lesion with device.
  9. Platelet count <50103/mm3 (50109/L) or any known coagulation deficiency, orInternational normalized ratio (INR)>3.0.
  10. Known hypersensitivity/allergies or contraindication to contrast media, stentcomponents, 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 thenext year.
  13. Currently enrolled in another investigational device or drug study.

Study Design

Total Participants: 204
Treatment Group(s): 3
Primary Treatment: SINOMED IAS Stent System
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

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