Real World Data in ChinaNCT03554850

Trevo® Retriever Registry (China)

An observational study of Real World Data in China, run by Stryker Neurovascular at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Real World Data in China
What is being tested?: Trevo® Retriever
Type of treatment: Medical device
How many people: 201 participants
Where: 10 sitesChina
Study dates: 30 Jan 2019to 2 Feb 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Populations met the inclusion/exclusion criteria above

Who may be able to join

Age ≥18
Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
Subject willing to comply with the protocol follow-up requirements

Who cannot join

mRS >2
Any known coagulopathy
Anticipated life expectancy less than 3 months
Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Beijing TianTan Hospital
Beijing, Beijing Municipality, 100050
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality, 101300
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Linyi People's Hospital
Linyi, Shandong, 276003
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Qingdao Central Hospital
Qingdao, Shandong, 266042
Qingyuan City People's Hospital
Qingyuan, Guangdong, 511518
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027

Other trials in China

About this study

Read the detailed description

Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.

Conditions: Real World Data in China
Being tested: Trevo® Retriever

What participants receive

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

Trevo® RetrieverDevice
Stent retriever procedure

What is being measured

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

the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure
The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method.
Note: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with <50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome.
Measured: At the end of the neuro-thrombectomy procedure (Day 1)

Secondary outcomes (4)

Day 90 mRS
good clinical outcomes defined as mRS of 0-2.
Measured: Day 90
Day 90 Mortality
If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90.
Measured: Day 90
Neurological Deterioration
Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.
Measured: 24 hours
Rate of Study Device and Procedure Related SAE Through Day 90
Rate of study device and procedure related serious adverse events (SAE) through Day 90.
Measured: Day 90

Timeline

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

30 Jan 20192 Feb 2021

First posted13 Jun 2018
Study start30 Jan 2019
Primary completion8 Sep 2020
Study completion2 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Real World Data in ChinaStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03554850
Sponsor's protocol ID: CDM10001400
Status last verified: May 2022
First submitted: 23 May 2018
Last updated: 27 May 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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?

See locations

RecruitingObservational study
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
Breast Cancer
Active, not recruitingObservational study
Southern Sichuan HIV Cohort Study Protocol
HIV - Human Immunodeficiency Virus
Active, not recruitingObservational study
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
Active, not recruitingObservational study
Prognostic Model of Elderly Hodgkin Lymphoma in China
Hodgkin Lymphoma

All Real World Data in China trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trevo® Retriever Registry (China)
ClinicalTrials.gov ID: NCT03554850
Acronym / sponsor ID: CDM10001400
Conditions: Real World Data in China
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Stryker NeurovascularIndustry (pharma, biotech, devices)
Study start: 30 Jan 2019 (actual)
Primary completion: 8 Sep 2020 (actual)
Study completion: 2 Feb 2021 (actual)
First posted: 13 Jun 2018 (actual)
Results: Posted 31 Jan 2022

Clinical summary

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

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Populations met the inclusion/exclusion criteria above

Key inclusion criteria (5 listed)

Age ≥18
Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
Subject willing to comply with the protocol follow-up requirements

Key exclusion criteria (6 listed)

mRS >2
Any known coagulopathy
Anticipated life expectancy less than 3 months
Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations

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
Trevo® RetrieverStent retriever procedure	Device	–

Primary outcome

the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure
Time frame: At the end of the neuro-thrombectomy procedure (Day 1)
The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method. Note: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with <50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome.

4 secondary outcomes

Day 90 mRS
Time frame: Day 90
Day 90 Mortality
Time frame: Day 90
Neurological Deterioration
Time frame: 24 hours
Rate of Study Device and Procedure Related SAE Through Day 90
Time frame: Day 90

Results and safety

Results posted to the registry on 31 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm-Trevo® Retriever	201	190

Primary outcome: the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure

Time frame: At the end of the neuro-thrombectomy procedure (Day 1). Count of participants. Unit: Participants

Measure	Primary Effectiveness Outcome n = 190
Value	187

Population analysed: The Trevo Retriever was used as the primary device in all subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: If the subjects completed their 90-day visit, the subjects were considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death was used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects were considered as alive at their Day 90. Otherwise, the subjects were counted as deaths before Day 90.. Other adverse events reported at 2.49% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Summary of All AEs and SAEs	11 of 201 (5.5%)	5 of 201 (2.5%)	11 of 201

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Real World Data in China

RecruitingObservational study
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
Breast Cancer
Active, not recruitingObservational study
Southern Sichuan HIV Cohort Study Protocol
HIV - Human Immunodeficiency Virus
Active, not recruitingObservational study
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
Active, not recruitingObservational study
Prognostic Model of Elderly Hodgkin Lymphoma in China
Hodgkin Lymphoma

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.

ZhongRong Miao, MD principal investigator

Beijing Tiantan Hospital

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

Questions about this trial

What is this clinical trial studying?

An observational study of Real World Data in China, run by Stryker Neurovascular at 10 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Yes. Results are posted in the registry (first posted 31 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure (time frame: At the end of the neuro-thrombectomy procedure (Day 1)). 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 NCT03554850.

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 27 May 2022.