Aneurysm Embolization System for Intracranial Aneurysms

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu CED Medtech Co., Ltd

About this trial

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)

Eligibility criteria

Qualifiers

sacculate;

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

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

Aneurysm diameter from 2mm to 15mm;

Disqualifiers

(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.

Trial design

Treatments tested in this trial

  • Implant an aneurysm embolization system

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators