Brain DiseasesNCT05829746

PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS

A study testing Tubridge in people with Brain Diseases and Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Brain Diseases, Aneurysm, Intracranial Aneurysm
What is being tested?: Tubridge
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteChina
Study dates: 3 Nov 2022to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(1) Age 18-75 years;
(2) Subjects with small to medium-sized aneurysms (aneurysm maximum diameter <10 mm) of the internal carotid artery or vertebral artery diagnosed by CTA, MRA or DSA angiography(including saccular aneurysms and recurrent saccular aneurysms) ;
(3) Aneurysm neck ≥ 4 mm or aneurysm body to neck ratio < 2;
(4) Parent artery diameter of 2.0 mm to 6.5 mm;
(5) Subjects suitable for treatment with the Tubridge stent alone or in combination with coil;
(6) The subject is willing to be followed up in accordance the protocol;
(7) The subject or the subject's guardian understands the purpose of the trial, voluntarily to participate and sign the informed consent form.

Who cannot join

(1) Aneurysm associated with AVM, MMD;
(2) Ruptured aneurysms within 30 days;
(3) Multiple aneurysms;
(4) Subjects with severe stenosis (≥50% stenosis) or occlusion of the parent artery;
(5) Aneurysms that have recurred after treatment with stents or stent-assisted coiling embolization
(6) Subjects with morphology or lesions that may interfere with the use of device , including but not limited to: carotid artery entrapment, vasculitis, aortic entrapment, restricted vascular access (e.g., severe intracranial vascular tortuosity, severe intracranial vasospasm that does not respond to pharmacologic therapy, other anatomic or clinical lesions that prevent device access)

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(7) Subjects who are unsuitable for anesthesia or endovascular surgery, such as major diseases of the heart, lungs, liver, spleen, or kidneys, malignant tumors of the brain, severe active infections, disseminated intravascular coagulation, and a history of severe psychiatric disorders;
(8) Subjects who have undergone major surgical procedures (e.g., implantation of internal fixation devices for fractures of the extremities, tumor resection, surgery on vital organs, etc.) within 30 days prior to signing the informed consent form or planned within 60 days after signing the informed consent form;
(9) mRS score ≥ 3;
(10) Subjects with a life expectancy of less than 12 months;
(11) Subjects who have participated in other drug or medical device clinical trials prior to enrollment and have not met the study endpoint time frame;
(12) Subjects who, in the judgment of the investigator, have poor adherence and are unable to complete the study as required;
(13) Subjects with a suspected history of allergy to materials such as nickel-titanium, platinum, or platinum-iridium alloys;
(14) Subjects who are unable to receive antiplatelet aggregation or anticoagulation therapy;
(15) Subjects who have had or are likely to have a reaction to contrast agents so severe that they are unable to complete pre-treatment medication;
(16) Women who are pregnant or breastfeeding;
(17) Other conditions deemed by the investigator to be inappropriate for study participation.

Trial locations and contacts

1 site in 1 country.

Huina Lu contact

15901703529

HuiNa.Lu@microport.com

China1 site, 1 recruiting

Shanghai Changhai Hospital
Shanghai
Jianmin Liu, Ph.D, liu118@vip.163.com
Recruiting

Other trials in China

About this study

Official title: PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS：PARAT MINI

A trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.

Conditions: Brain Diseases, Aneurysm, Intracranial Aneurysm, Cardiovascular Diseases
Being tested: Tubridge
Medical subject headings: Brain Diseases, Aneurysm, Intracranial Aneurysm, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TubridgeDevice
Intracranial stent for wide-necked aneurysms

Study groups in NCT05829746
Study group	Role	What they receive
Intervention group	Experimental	Microport NeuroTech Tubridge flow-diverter Stent Receives: Device: Tubridge

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 180±30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202231 Dec 2024

First posted26 Apr 2023
Study start3 Nov 2022
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Brain DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05829746
Sponsor's protocol ID: Tubridge-2022-02-0A
Status last verified: Apr 2023
First submitted: 13 Apr 2023
Last updated: 26 Apr 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Huina Lu

15901703529

HuiNa.Lu@microport.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS：PARAT MINI
ClinicalTrials.gov ID: NCT05829746
Acronym / sponsor ID: Tubridge-2022-02-0A
Conditions: Brain Diseases, Aneurysm, Intracranial Aneurysm, Cardiovascular Diseases
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 65 participants (estimated)
Lead sponsor: MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Nov 2022 (actual)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 26 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention group	Experimental	Device: TubridgeMicroport NeuroTech Tubridge flow-diverter Stent

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

(1) Age 18-75 years;
(2) Subjects with small to medium-sized aneurysms (aneurysm maximum diameter <10 mm) of the internal carotid artery or vertebral artery diagnosed by CTA, MRA or DSA angiography(including saccular aneurysms and recurrent saccular aneurysms) ;
(3) Aneurysm neck ≥ 4 mm or aneurysm body to neck ratio < 2;
(4) Parent artery diameter of 2.0 mm to 6.5 mm;
(5) Subjects suitable for treatment with the Tubridge stent alone or in combination with coil;

Key exclusion criteria (17 listed)

(1) Aneurysm associated with AVM, MMD;
(2) Ruptured aneurysms within 30 days;
(3) Multiple aneurysms;
(4) Subjects with severe stenosis (≥50% stenosis) or occlusion of the parent artery;
(5) Aneurysms that have recurred after treatment with stents or stent-assisted coiling embolization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TubridgeIntracranial stent for wide-necked aneurysms	Device	Intervention group

Primary outcome

Complete occlusion rate of aneurysms
Time frame: 180±30 days
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huina Lu contact

15901703529

HuiNa.Lu@microport.com

Jianmin Liu principal investigator

Changhai Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tubridge in people with Brain Diseases and Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huina Lu (15901703529, HuiNa.Lu@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete occlusion rate of aneurysms (time frame: 180±30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.