Tubridge Flow Diverter Study For Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

— TRACE-IA  

Official title:

Tubridge Flow Diverter Study For Intracranial Aneurysms: A Post Market Nationwide Multi-center Registry Study In China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05646108
• Other study ID #: Tubridge-2022-01-A
• Status: Active, not recruiting
• Start date: April 18, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2022
• Source: MicroPort NeuroTech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The scope of this trial is the collection and analysis of the important safety outcomes in the real world, related to the use of the Tubridge flow diverter in the treatment of intracranial aneurysms.

Description:

A cerebral aneurysm (also known as an intracranial or intracerebral aneurysm) is a weak or thin spot on a blood vessel in the brain that balloons out and fills and intermixes with parent artery blood. Incidence of intracranial aneurysms varies by country, with reports of prevalence ranging from 5.1 to 19.6 cases per 100,000 persons. The most devastating presentation of an intracranial aneurysm is subarachnoid hemorrhage (SAH). It is estimated that, on average, five percent of the population is afflicted and the incidence of aneurysm rupture (SAH) is between 6 and 9 per 1000 000 individuals .Mortality can approach 50%, with fewer than 60% of survivors returning to independent living.

Invasive treatment of aneurysms began with an open surgical procedure referred to as 'surgical clipping'. This treatment was once considered the gold standard treatment for aneurysms. Traditional surgery requires craniotomy to reach the aneurysm in the brain and place the clip on the neck (opening) of the aneurysm to block the blood flow into the aneurysm. It usually has a higher complication rate and mortality rate. In contrast to the surgery, endovascular treatment via a minimally invasive procedure Endovascular treatment has become the mainstream treatment of intracranial aneurysms, which consists of coiling, stent-assisted coiling, and flow diversion.

Flow diverter is a stent-like device with low-porosity and higher metal coverage would significantly change the direction of the blood flow, reduce the hemodynamic impact on the aneurysmal necks, and further induce intra-saccular thrombogenesis; also, they would serve as scaffolds to promote intima formation, which has a distinct effect on the healing of aneurysmal necks. Meanwhile, due to the pressure gradient between the main trunk and perforators, those perforators would keep patent. The emergence of the flow diverter shows the treatment of the brain aneurysm changed from the concept of aneurysm sac packing to the hemodynamic reconstruction of the parent vessel.

In recent years, commercialized flow diverter represented as pipeline embolization device (Medtronic, Irvine, California, USA) which is braided strands of cobalt chromium and platinum, and Silk Flow Diverter (Balt Extrusion, Montmorency, France) which is braided from nitinol wires. One potential technical concern with different material or design for FD is that of may lead to different flow reduction effects or mechanical properties, which can result in neurologic complications. Tubridge flow diverter is a self-expended stent which is braided of nickel-titanium microfilaments with two platinum-iridium microfilaments through the entire stent. It has been in commercial clinical use in China since April 2018. Here, the investigator conducted a post market, nationwide, multicenter registry research on embolization of intracranial aneurysms with tubridge flow diverter in China, to evaluate the important clinical outcomes in real-world use.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1. received Tubridge flow diverter treatment for intracranial aneurysm after the date of regulatory approval in China

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Endovascular treatment
Endovascular treatment

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

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	The primary end point was the event-free survival rate at 12 months(Plus 0.5 month).	defined as the occurrence of morbidity (ispontaneous rupture of the target aneurysm causing subarachnoid hemorrhage or cavernous carotid fistula, intraparenchymal hemorrhage (IPH)(both ipsilateral and contralateral), ischemic stroke, and permanent cranial neuropathy,or death within 12 months(Plus 0.5 month) post-treatment.For the Tubridge flow diverter, this endpoint will be based upon the evaluation of clinical event committee, identification of patients with neurologic clinical events after Tubridge flow diverter treatment, including but not limited: Spontaneous rupture of the target aneurysm, Intraparenchymal hemorrhage, Ischemic stroke, cranial neuropathy.Transient ischemic stroke without clinical adverse events was not included.	12 months (Plus 0.5 month)
Secondary	The clinical outcome defined by the mRS at 12 months (Plus 0.5 month) after aneurysm treatment.	In patients where mRS at 12months were not available, the last available mRS was used instead;	12 months (Plus 0.5 month)
Secondary	Occurrence of ipsilateral major stroke or neurovascular death in 1 months (Plus 7 days), including but not limited: Spontaneous rupture of the target aneurysm, ipsilateral intraparenchymal hemorrhage, ipsilateral ischemic stroke, cranial neuropathy.		1 months (Plus 7 days)
Secondary	The event-free survival rate at 24 months(Plus 0.5 month);		24 months(Plus 0.5 month)
Secondary	The event-free survival rate at 36 months(Plus 0.5 month);		36 months(Plus 0.5 month)
Secondary	The event-free survival rate at 48 months(Plus 0.5 month);		48 months(Plus 0.5 month)
Secondary	Median event-free survival time		4 years