Clinical trial NCT05774782: Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
Official title: A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Cerebral Aneurysm Unruptured
Keywords: flow diverter
endovascular therapy
Lead sponsor: Sinomed Neurovita Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2023-03-20
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Detailed description: The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary endpoint is success aneurysm occlusion at 1 year post procedure.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years to 75 years, male or non-pregnant female.
2. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2).
3. Parent vessel with a diameter range of 1.75-6.0 mm.
4. Those who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
2. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
3. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
4. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-\[Tris(hydroxymethyl)methyl\] acrylamide (poly-NTMA).
5. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
6. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
7. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
8. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
9. The survival expectation is less than 1 year.
10. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
11. Inapplicable for this study at the investigators' viewpoints.

Primary outcomes:
measure: Success aneurysm occlusion at 1 year post procedure
timeFrame: 1 year post procedure
Secondary outcomes:
measure: Immediate procedural success rate
timeFrame: Intra-procedure
measure: Complete aneurysm occlusion rate at 180 days and 1 year post procedure
timeFrame: 180 days, 1 year post procedure
measure: Success aneurysm occlusion at 180 days post procedure
timeFrame: 180 days post procedure
measure: Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure
timeFrame: 180 days, 1 year post procedure
measure: All-cause mortality at 30 days, 180 days and 1 year post procedure
timeFrame: 30 days, 180 days and 1 year post procedure
measure: Any stroke at 30 days, 180 days and 1 year post procedure
timeFrame: 30 days, 180 days and 1 year post procedure
measure: Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure
timeFrame: 180 days and 1 year post procedure
measure: Target aneurysmal hemorrhage at 180 days and 1 year post procedure
timeFrame: 180 days and 1 year post procedure
measure: Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure
timeFrame: 180 days and 1 year post procedure
measure: Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure
timeFrame: hospitalization, 30 days, 180 days and 1 year post procedure
measure: Rate of Device defect
timeFrame: within 1 year of whole trial
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Hongqi Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: