Bioabsorbable/Nufairy Coil Application Trial in China

NCT ID: NCT06466564

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-24
• Study Completion Date: 2026-06-01

Brief Summary

The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.

Detailed Description

Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Bioabsorbable/Nufairy coil embolization system

Group Type: EXPERIMENTAL

Nufairy® Coil embolization system for intracranial aneurysm

Intervention Type: DEVICE

Nufairy® Coil embolization system for intracranial aneurysm

Control group

Numen coil embolization system

Group Type: ACTIVE_COMPARATOR

Nufairy® Coil embolization system for intracranial aneurysm

Intervention Type: DEVICE

Nufairy® Coil embolization system for intracranial aneurysm

Interventions

Nufairy® Coil embolization system for intracranial aneurysm

Nufairy® Coil embolization system for intracranial aneurysm

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;

2. Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination;

3. Subjects whose target aneurysms are suitable for embolization with flow diverter or intracranial arterial stents assisted by coils, and the entire treatment can be performed in a single procedure;

4. The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up.

Exclusion Criteria

1. mRS Score ≥3 points in clinical assessment prior to enrollment;

2. Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;

3. Subjects with multiple aneurysms;

4. Subjects with ruptured aneurysms <30 days;

5. Significant stenosis (≥50%) of parent artery;

6. Subjects who are not suitable for anesthesia or intravascular surgery, such as major diseases of the heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, and a history of serious mental illness;

7. Subjects who have undergone major surgical procedures (such as internal fixation device implantation of limbs fracture, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent or plan to undergo major surgical procedures within 60 days after signing the informed consent;

8. Subjects with morphology or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, limited vascular access (e.g., severe intracranial vessel tortuosity, severe intracranial vessel spasm that does not respond to medical treatment, other anatomical or clinical changes that impede device access;

9. Treatment contrainidations of coils, including but not limited to: contrainidations of digital subtraction angiography, allergy to or intolerance of contrast agents, allergy to or intolerance of anti-platelet and anticoagulant drugs required for treatment, platinum-tungsten alloy, and poly(co-glycolic acid) (PLGA);

10. Pregnant or lactating women;

11. Life expectancy is less than 18 months;

12. Subjects participating in other drug or device studies did not meet the endpoint.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort NeuroTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Shanghai Changhai Hospital

Shanghai, , China

Countries

China

Other Identifiers

SSTH-2023-02-0A

Identifier Type: -

Identifier Source: org_study_id