Tubridge Flow Diverter Study For Intracranial Aneurysms (TRACE-IA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Endovascular treatment

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Child, Adult, Older Adult

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
The event-free survival rate at 24 months(Plus 0.5 month);		24 months(Plus 0.5 month)
The event-free survival rate at 36 months(Plus 0.5 month);		36 months(Plus 0.5 month)
The event-free survival rate at 48 months(Plus 0.5 month);		48 months(Plus 0.5 month)
Median event-free survival time		4 years

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.
• Investigators: Study Chair: Jianmin Liu, Ph.D, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: cerebral aneurysm; flow diverter; Intracranial aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Tubridge-2022-01-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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