Evaluate the efficacy and safety of the use of a-Stent (coil-assist stent)

Investigator-Intended clinical trial to evaluate the efficacy and safety of the use of a-Stent (coil-assist stent) coil embolization of Wide-neck Saccular aneurysms: single center, single group, prospective clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005841

Enrollment

Registered

2021-01-28

Start date

2021-01-21

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Subjects enrolled in this study are prepared for the procedure, and receive&#39

a-Stent&#39

-coil embolization. &#39

?-Stent&#39

-coil embolization must be performed under general anesthesia. Arterial access is obtained through access to the femoral artery, brachial artery, or radial artery, and a vascular sheath will be insert

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 75 years old 2) Those in need of treatment due to unruptured Wide-neck Saccular Aneurysm 3) A person who voluntarily decides to participate in this clinical trial and signs a consent form

Exclusion criteria

Exclusion criteria: 1) If an aneurysm is ruptured 2) If you currently have two tumors or are receiving radiation therapy for carcinoma or sarcoma in the head and neck 3) If you have a heart disease that is likely to be related to heart embolism symptoms such as atrial fibrillation (AFIB) 4) If the patient is at high risk of embolic stroke according to the investigator opinion 5) Patients contraindicated with anticoagulants, antiplatelet drugs or thrombolytic drugs 6) Arteriovenous malformation in aneurysms 7) If it is judged that participation in this clinical trial is inappropriate according to the judgment of other researchers [Items to be confirmed on the day of coil embolization] 8) When there is difficulty in passing or placing the stent due to an anatomical problem 9) In case the aneurysm is not suitable for endovascular treatment during the actual procedure

Design outcomes

Primary

Measure	Time frame
Cerebral aneurysm occlusion success rate at 6 months after the procedure (%)	—

Secondary

Measure	Time frame
Incidence of complications after stent procedure (%);Recure rate (%);Stent procedure success rate (%)	—

Countries

Korea, Republic of

Contacts

Public ContactJung Ho

Yonsei University Health System, Severance Hospital

Outcome results