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

June 1, 2023 updated by: MicroPort NeuroTech Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Chendu, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Xiaodong Xie
      • Shanghai, China
        • Recruiting
        • Huashan Hospital of Fudan University
        • Contact:
          • Yuxiang Gu
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Jianming Liu
      • Shenzhen, China
        • Not yet recruiting
        • Clinical Research Ethics Committee of Shenzhen Second People's Hospital
        • Contact:
          • Jianming Wu
      • Wuhan, China
        • Not yet recruiting
        • Zhongnan Hospital, Wuhan University
        • Contact:
          • Jingcao Chen
      • Xi'an, China
        • Recruiting
        • The Second Affiliated Hospital of PLA Air Force Military Medical University
        • Contact:
          • Zhenwei Zhao
      • Zhengzhou, China
        • Not yet recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Sheng Guan
      • Zhujiang, China
        • Recruiting
        • Zhujiang Hospital,Southern Medical University
        • Contact:
          • Chuanzhi Duan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Device: Microport NeuroTech Tubridge Plus flow-diverter Stent
Intracranial stent for wide-necked aneurysms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
Time Frame: 6months±30 days
Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
6months±30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures
Time Frame: 12months±60 days
Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures
12months±60 days
Successful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures
Time Frame: 6months±30 days
uccessful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures
6months±30 days
Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures
Time Frame: 12months±60 days
Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures
12months±60 days
Retreatment rate of target aneurysm during follow-up
Time Frame: 12months±60 days
Retreatment rate of target aneurysm during follow-up
12months±60 days
Success rate of stent implantation
Time Frame: Immediate evaluation after intervention
Success rate of stent implantation
Immediate evaluation after intervention
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;
Time Frame: 12months±60 days
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
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
Time Frame: 6months±30 days
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
6months±30 days
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
Time Frame: 6months±30 days
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
6months±30 days
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
Time Frame: 12months±60 days
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
12months±60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort NeuroTech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB2-2021-01-0A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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