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Intracranial AneurysmNCT05898893

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

A study testing Microport NeuroTech Tubridge Plus flow-diverter Stent in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 8 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Microport NeuroTech Tubridge Plus flow-diverter Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
8 sitesChina
Study dates
16 May 2023to 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

  • Age 18-75 years old (as of the date of signing the informed consent form);
  • 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);
  • The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm < 2;
  • The diameter of the parent vessel is 2.0mm-6.5mm;
  • Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;
  • Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;
  • The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.

Who cannot join

  • Aneurysm related to AVM and MMD;
  • Ruptured aneurysm within 30 days;
  • Multiple aneurysms;
  • Subjects with significant stenosis (stenosis rate >= 50%) or occlusion of parent artery
  • Recurrent aneurysms after stent or stent-assisted coil embolization;
  • 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);
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  • 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;
  • 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;
  • Modified Rankin score >= 4 points ;
  • The life expectancy of the subjects is less than 12 months;
  • Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.
  • The researchers judged that the subjects had poor compliance and could not complete the study as required;
  • Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;
  • Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
  • Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;
  • Women who are pregnant or breastfeeding;
  • Other conditions deemed inappropriate by the investigator to participate in the study.

Trial locations and contacts

8 sites in 1 country.

Huina Lu contact

15901703529

HuiNa.Lu@microport.com

8 sites in 1 country

China8 sites, 8 recruiting

  • West China Hospital of Sichuan University

    Chendu

    Xiaodong Xie

    Not yet recruiting

  • Huashan Hospital of Fudan University

    Shanghai

    Yuxiang Gu

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai

    Jianming Liu

    Not yet recruiting

  • Clinical Research Ethics Committee of Shenzhen Second People's Hospital

    Shenzhen

    Jianming Wu

    Not yet recruiting

  • Zhongnan Hospital, Wuhan University

    Wuhan

    Jingcao Chen

    Not yet recruiting

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi'an

    Zhenwei Zhao

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Sheng Guan

    Not yet recruiting

  • Zhujiang Hospital,Southern Medical University

    Zhujiang

    Chuanzhi Duan

    Recruiting

Other trials in China

About this study

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

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

Being tested
Microport NeuroTech Tubridge Plus flow-diverter Stent
Medical subject headings
Intracranial Aneurysm

What participants receive

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

  • Microport NeuroTech Tubridge Plus flow-diverter StentDevice

    Intracranial stent for wide-necked aneurysms

Study groups in NCT05898893
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Device: Microport NeuroTech Tubridge Plus flow-diverter Stent

What is being measured

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

  1. Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures

    Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures

    Measured: 6months±30 days

Secondary outcomes (9)

  1. Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures

    Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures

    Measured: 12months±60 days

  2. 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

    Measured: 6months±30 days

  3. 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

    Measured: 12months±60 days

  4. Retreatment rate of target aneurysm during follow-up

    Retreatment rate of target aneurysm during follow-up

    Measured: 12months±60 days

  5. Success rate of stent implantation

    Success rate of stent implantation

    Measured: Immediate evaluation after intervention

  6. 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;

    Measured: 12months±60 days

  7. 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

    Measured: 6months±30 days

  8. 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

    Measured: 6months±30 days

  9. 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

    Measured: 12months±60 days

Timeline

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

  1. First posted12 Jun 2023
  2. Study start16 May 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898893
Sponsor's protocol ID
TB2-2021-01-0A
Status last verified
May 2023
First submitted
11 May 2023
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Microport NeuroTech Tubridge Plus flow-diverter Stent in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 8 sites 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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（Raymond I） rate of aneurysm at 6 months after procedures (time frame: 6months±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 NCT05898893.

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 12 Jun 2023.

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