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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Brain Diseases; Aneurysm; Intracranial Aneurysm
• Intervention / Treatment: Device: Intracranial stent for wide-necked aneurysms

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huina Lu; Phone Number: 15901703529; Email: HuiNa.Lu@microport.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: Sheng Guan; Email: gsradio@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Microport NeuroTech Intracranial Visualized Stent	Device: Intracranial stent for wide-necked aneurysms; Intracranial stent for wide-necked aneurysms
Active Comparator: control group; LVIS™ and LVIS™ Jr	Device: Intracranial stent for wide-necked aneurysms; Intracranial stent for wide-necked aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Retreatment rate	Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up	Time Frame: 360±30 days
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
Incidence od in-stent stenosis (≥50%)		Time Frame: 360±30 days
Incidence of device-relared stroke or death		perioperative
Incidence of ipsilateral stroke of neurological death		Time Frame: 360±30 days
Incidence of device-related severe adverse event		Time Frame: 360±30 days
Incidence of aneurysm rupture		Time Frame: 360±30 days

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Cardiovascular Diseases; Brain Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Mermaid-2021-01-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No