Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

Sinomed Neurovita Technology Inc.143 enrolled

Overview

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

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 efficacy endpoint was complete aneurysm occlusion with parent artery stenosis ≤ 50% at one year post-procedure in the absence of additional treatments, while the primary safety endpoint was no major stroke in the treated artery territory or neurological death at one year post-procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Cerebral Aneurysm Cerebral Aneurysm Unruptured

Interventions

Cerebral flow diverterDEVICE

The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 1 year post procedure

Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year.

Time frame: 1 year post procedure

Major stroke in the territory supplied by the treated artery or neurological death at 1 year post procedure

National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.

Time frame: 1 year post procedure

Secondary Outcomes

Immediate procedural success rate

Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.

Time frame: Intra-procedure

Complete aneurysm occlusion rate at 180 days and 1 year post procedure

Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).

Time frame: 180 days, 1 year post procedure

Success aneurysm occlusion at 180 days and 1 year post procedure

The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days and 1 year follow-up angiographic assessments will be evaluated.

Data from ClinicalTrials.gov

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