PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)

Intracranial Aneurysm Clinical Trial

Official title:

Prospective, Multi-Center, Open-Label, Single-Arm Registration Trial Of The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898893
• Other study ID #: TB2-2021-01-0A
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• 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 trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old (as of the date of signing the informed consent form);

2. CTA, MRA or DSA angiography diagnosed as a large intracranial carotid artery or vertebral artery aneurysm (largest diameter of the aneurysm >= 10mm) or medium to small aneurysms (maximum diameter <10mm) (including saccular aneurysms and recurrent saccular aneurysms);

3. The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm < 2;

4. The diameter of the parent vessel is 2.0mm-6.5mm;

5. Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;

6. Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;

7. The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.

Exclusion Criteria:

1. Aneurysm related to AVM and MMD;

2. Ruptured aneurysm within 30 days;

3. Multiple aneurysms;

4. Subjects with significant stenosis (stenosis rate >= 50%) or occlusion of parent artery

5. Recurrent aneurysms after stent or stent-assisted coil embolization;

6. Subjects with morphologies or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, Aortic dissection, restriction of vascular access (such as severe intracranial vascular tortuosity, severe intracranial vasospasm and no response to drug therapy, obstruction of device access due to other anatomical or clinical lesions);

7. Subjects who are not suitable for anesthesia or endovascular treatment, such as severe diseases of the heart, lung, liver, spleen, and kidney, brain tumors, severe active infection, disseminated intravascular coagulation, and a history of severe mental illness;

8. Subjects who underwent or plan undergo to major surgical operations (such as implantation of internal fixation devices for extremity fractures, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent form or 60 days after signing the informed consent form;

9. Modified Rankin score >= 4 points ;

10. The life expectancy of the subjects is less than 12 months;

11. Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.

12. The researchers judged that the subjects had poor compliance and could not complete the study as required;

13. Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;

14. Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;

15. Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;

16. Women who are pregnant or breastfeeding;

17. Other conditions deemed inappropriate by the investigator to participate in the study.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Microport NeuroTech Tubridge Plus flow-diverter Stent
Intracranial stent for wide-necked aneurysms

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chendu
China	Huashan Hospital of Fudan University	Shanghai
China	Shanghai Changhai Hospital	Shanghai
China	Clinical Research Ethics Committee of Shenzhen Second People's Hospital	Shenzhen
China	Zhongnan Hospital, Wuhan University	Wuhan
China	The Second Affiliated Hospital of PLA Air Force Military Medical University	Xi'an
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Zhujiang Hospital,Southern Medical University	Zhujiang

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	Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures	Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures	6months±30 days
Secondary	Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures	Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures	12months±60 days
Secondary	Successful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures	uccessful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures	6months±30 days
Secondary	Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures	Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures	12months±60 days
Secondary	Retreatment rate of target aneurysm during follow-up	Retreatment rate of target aneurysm during follow-up	12months±60 days
Secondary	Success rate of stent implantation	Success rate of stent implantation	Immediate evaluation after intervention
Secondary	The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;	The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;	12months±60 days
Secondary	The proportion of subjects with in-stent stenosis (stenosis =50% and <100%) within 6 months after procedures	The proportion of subjects with in-stent stenosis (stenosis =50% and <100%) within 6 months after procedures	6months±30 days
Secondary	Proportion of subjects with complete in-stent occlusion within 6 months after procedures	Proportion of subjects with complete in-stent occlusion within 6 months after procedures	6months±30 days
Secondary	Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures	Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures	12months±60 days