Bioabsorbable/Nufairy Coil Application Trial in China

NCT06466564 | Active Not Recruiting DMC

• 1 other identifier: SSTH-2023-02-0A
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Successful occlusion rate of aneurysm at 12-month post-procedure.

  It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization).

  12 month

Secondary Outcomes (6)

• Complete occlusion rate of aneurysm at 12-month post-procedure.

  12 month

• Recurrence rate of aneurysm at 12-month post-procedure.

  12 month

• Retreatment rate of aneurysm at 12-month post-procedure.

  12 month

• Device-related serious adverse events at 1, 6, and 12 months after surgery;

  12 month

• The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months.

  12 month

Other Outcomes (5)

• Successful occlusion rate of aneurysm at 18-month post-procedure.

  18 month

• Recurrence rate of aneurysm at 18-month post-procedure.

  18 month

• Retreatment rate of aneurysm at 18-month post-procedure.

  18 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Bioabsorbable/Nufairy coil embolization system

Device: Nufairy® Coil embolization system for intracranial aneurysm

Control group

ACTIVE COMPARATOR

Numen coil embolization system

Device: Nufairy® Coil embolization system for intracranial aneurysm

Interventions

Nufairy® Coil embolization system for intracranial aneurysm DEVICE

Nufairy® Coil embolization system for intracranial aneurysm

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
• Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination;
• 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;
• The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up.

You may not qualify if:

• mRS Score ≥3 points in clinical assessment prior to enrollment;
• Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;
• Subjects with multiple aneurysms;
• Subjects with ruptured aneurysms \<30 days;
• Significant stenosis (≥50%) of parent artery;
• 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;
• 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;
• 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;
• 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);
• Pregnant or lactating women;
• Life expectancy is less than 18 months;
• Subjects participating in other drug or device studies did not meet the endpoint.

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: June 20, 2024
• Study Start: December 24, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CN (1)