Trevo® Retriever Registry (China)

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.

Study Overview

• Status: Completed
• Conditions: Real World Data in China
• Intervention / Treatment: Device: Trevo® Retriever

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.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Populations met the inclusion/exclusion criteria above

Description

Inclusion Criteria:

1. Age ≥18
2. 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
3. Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
4. Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
5. Subject willing to comply with the protocol follow-up requirements

Exclusion Criteria:

1. mRS >2
2. Any known coagulopathy
3. Anticipated life expectancy less than 3 months
4. Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
5. Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
6. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the neuro-thrombectomy procedure (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 90 mRS	good clinical outcomes defined as mRS of 0-2.	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.	Day 90
Neurological Deterioration	Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.	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.	Day 90

Collaborators and Investigators

• Sponsor: Stryker Neurovascular

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2019
• Primary Completion (ACTUAL): September 8, 2020
• Study Completion (ACTUAL): February 2, 2021

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CDM10001400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes