Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms

Cardiovascular Diseases Clinical Trial

— PROMISE  

Official title:

Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275296
• Other study ID #: Mermaid-2021-01-A
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: MicroPort NeuroTech Co., Ltd.
• Contact: Huina Lu
• Phone: 15901703529
• Email: HuiNa.Lu[@]microport.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;

• Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck =4mm, or body-neck ratio <2) by DSA/CTA/MRA;

• The diameter of the parent vessel should be 2.0 to 4.5mm;

• The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;

• Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.

Exclusion Criteria:

• Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;

• Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;

• Subject with multiple aneurysms that cannot be treated by single stent;

• Subject with aneurysm ruptured within 30 days;

• Subject who is not suitable for anesthesia or endovascular surgery;

• Subject with significant stenosis of the parent arterty(>50%)

• Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;

• Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;

• Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;

• Subject who is contraindicated with stent-assisted coiling:

Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.

• Women who is pregnant or now breastfeeding;

• Subject with a life expectancy less than 12 months.

Related Conditions & MeSH terms

• Aneurysm
• Brain Diseases
• Cardiovascular Diseases
• Intracranial Aneurysm

Intervention

Device:
• Intracranial stent for wide-necked aneurysms
Intracranial stent for wide-necked aneurysms

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort NeuroTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate occlusion rate of aneurysms	The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.	Time Frame: 360±60 days
Secondary	Complete occlusion rate of aneurysms	The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Complete occlusion rate includes Class I	Time Frame: 360±30 days
Secondary	Retreatment rate	Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up	Time Frame: 360±30 days
Secondary	Successful stent placement	Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.	Intraoperation
Secondary	Incidence od in-stent stenosis (=50%)		Time Frame: 360±30 days
Secondary	Incidence of device-relared stroke or death		perioperative
Secondary	Incidence of ipsilateral stroke of neurological death		Time Frame: 360±30 days
Secondary	Incidence of device-related severe adverse event		Time Frame: 360±30 days
Secondary	Incidence of aneurysm rupture		Time Frame: 360±30 days