Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent (CRANIAL-2)

Naval Military Medical University

Status

Unknown

Conditions

Self Efficacy

Medical Device Complication

Treatments

Device: LVIS stent

Study type

Observational

Funder types

Other

Identifiers

NCT02830386

CHEC2016-059

Details and patient eligibility

About

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.

Full description

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients meeting all the following criteria will be enrolled:
1. Patients of the age 18-75 years old.
2. Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.
3. Patients treated with LVIS stents combined with coils.
4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.
5. Patients accepting to participate to the study and sign the consent forms.

Exclusion criteria

Patients meeting any following criterion will be excluded
1. Patients without proper artery approach.
2. Patients with AVM.
3. Patients with a fusiform or dissecting aneurysm.
4. Patients with a recurrent aneurysm.
5. Patients treated with a LVIS stent without coils.
6. Patients in poor clinical status, with mRS ≥4.
7. Patients with life expectancy less than 12 months.
8. Patients participated in other clinical trial, while has not reach the primary endpoint.
9. Patients can not accept anti-platelet regimen.
10. Patients allergic to contrast agent or intolerable.
11. Patients whom the researchers consider should not participate in or continue this clinical trial.