Aneurysm Embolization System for Intracranial Aneurysms

NCT ID: NCT06485492

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-31

Brief Summary

The purpose of this clinical study was to evaluate the safety and efficacy of the aneurysm embolization system produced by Jiangsu Changyida Medical Technology Co., Ltd. in patients with intracranial aneurysms (including ruptured aneurysms)

Conditions

Ruptured Cerebral Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: EXPERIMENTAL

Implant an aneurysm embolization system

Intervention Type: PROCEDURE

The product uses minimally invasive interventional method to treat intracranial aneurysms approved for application. The study physician selects the appropriate size and/or shape of the aneurysm based on the size and shape of the intracranial arterioma. The aneurysm embolization system device is inserted into the arterioma through a compatible neurovascular microcatheter.

Interventions

Implant an aneurysm embolization system

The product uses minimally invasive interventional method to treat intracranial aneurysms approved for application. The study physician selects the appropriate size and/or shape of the aneurysm based on the size and shape of the intracranial arterioma. The aneurysm embolization system device is inserted into the arterioma through a compatible neurovascular microcatheter.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• (1) Age ≥18 years old, and ≤75 years old, male or female; (2) There was an unruptured aneurysm or a single ruptured aneurysm requiring treatment, and the Hunt-Hess score was grade I-III; (3) The target aneurysm to be treated must have the following characteristics:

1. sacculate;

2. aneurysms located in anterior communicating artery, middle cerebral artery bifurcation aneurysms and basilar artery apex aneurysms;

3. The diameter of the aneurysm is in accordance with the instruction manual of the aneurysm embolization system for treatment;

4. Aneurysm diameter from 2mm to 15mm;

5. Tumor body/neck (D/N) ratio ≥1;

6. Tumor neck ≥4mm or tumor body/neck (D/N) ratio < 2; (4) The target aneurysm is suitable for aneurysm embolization system treatment; (5) The subject is able to understand the purpose of the study, demonstrates sufficient adherence to the study protocol, and is able and willing to sign the informed consent.

Exclusion Criteria

• (1) Patients with aneurysms who are not suitable for endovascular therapy; (2) The microcatheter could not reach the target aneurysm of the patient after being shaped, and could not be treated with research instruments; (3) There are risk factors for ischemic stroke, or ischemic symptoms that have occurred within the last 30 days, such as transient ischemic attack, minor stroke, or progressive stroke; (4) The presence of cerebrovascular, cardiovascular or neurological diseases that cause instability of neurological symptoms; (5) mRS≥ 2 before the onset of symptoms or rupture of the aneurysm (if applicable); (6) Patients with intracranial hypertension or other intracranial hematoma within 90 days requiring elective surgery; (7) Patients who are being treated with anticoagulants or who currently have malignant diseases of the blood system, coagulation diseases or hemoglobinopathy; (8) Patients who are allergic to any component of the research instrument, surgical material or drugs used during the operation and cannot be effectively treated; (9) Patients whose life expectancy is less than 2 years due to other diseases or conditions (other than intracranial aneurysms); (10) Patients with mental disorders; (11) Women who are pregnant or breastfeeding, or who have a birth plan in the next 3 months; (12) Patients who are participating in any other drug or medical device clinical trial, or who may participate in any other drug or medical device clinical trial after enrollment in this clinical trial; (13) The investigator determines that there are other conditions that are not suitable for participation in this clinical trial.

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

Sponsors

Jiangsu CED Medtech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Jindou Feng

archiater

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qiufang Xu

Role: CONTACT

qf.x@neulive.cn

13962192467

Other Identifiers

CER-A-AES-01

Identifier Type: -

Identifier Source: org_study_id