Clinical trial NCT06485492: Aneurysm Embolization System for Intracranial Aneurysms
Official title: Prospective, Multicenter Design of Clinical Trials to Evaluate the Safety and Efficacy of Aneurysm Embolization Systems for the Treatment of Intracranial Aneurysms, Including Ruptured Aneurysms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ruptured Cerebral Aneurysm
Lead sponsor: Jiangsu CED Medtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, single-group, target-controlled clinical study
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Adequate embolization rate at 1 year follow-up.
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: