Trevo® Retriever Registry (China)

• ClinicalTrials.gov Identifier: NCT03554850
• Recruitment Status: Completed
• First Posted: June 13, 2018
• Results First Posted: January 31, 2022
• Last Update Posted: January 31, 2022
• Sponsor: Stryker Neurovascular
• Information provided by (Responsible Party): Stryker Neurovascular

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Real World Data in China	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 Design

• Study Type: Observational
• Actual Enrollment: 201 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Trevo® Retriever Registry (China)
• Actual Study Start Date: January 30, 2019
• Actual Primary Completion Date: September 8, 2020
• Actual Study Completion Date: February 2, 2021

Groups and Cohorts

Intervention Details:

• Device: Trevo® Retriever
  Stent retriever procedure

Outcome Measures

Primary Outcome Measures :

1. the Modified TICI 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.

Secondary Outcome Measures :

1. Day 90 mRS [ Time Frame: Day 90 ]
   good clinical outcomes defined as mRS of 0-2.
2. Day 90 Mortality [ Time Frame: Day 90 ]
   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.
3. Neurological Deterioration [ Time Frame: 24 hours ]
   Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.
4. Rate of Study Device and Procedure Related SAE Through Day 90 [ Time Frame: Day 90 ]
   Rate of study device and procedure related serious adverse events (SAE) through Day 90.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Populations met the inclusion/exclusion criteria above

Criteria

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.

Contacts and Locations

Locations

China, Beijing

Beijing TianTan Hospital

Beijing, Beijing, China, 100050

The Hospital of Shunyi District Beijing

Beijing, Beijing, China, 101300

China, Guangdong

Qingyuan City People's Hospital

Qingyuan, Guangdong, China, 511518

China, Hebei

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050051

China, Henan

Puyang Oilfield General Hospital

Puyang, Henan, China, 457001

China, Shandong

Linyi People's Hospital

Linyi, Shandong, China, 276003

Qingdao Central Hospital

Qingdao, Shandong, China, 266042

China, Zhejiang

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310016

Wenzhou Central Hospital

Wenzhou, Zhejiang, China, 325000

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325027

Sponsors and Collaborators

Stryker Neurovascular

Investigators

• Principal Investigator: ZhongRong Miao, MD; Beijing Tiantan Hospital

  Study Documents (Full-Text)

Documents provided by Stryker Neurovascular:

Study Protocol  [PDF] November 27, 2017

Statistical Analysis Plan  [PDF] August 15, 2018

More Information

• Responsible Party: Stryker Neurovascular
• ClinicalTrials.gov Identifier: NCT03554850
• Other Study ID Numbers: CDM10001400
• First Posted: June 13, 2018
• Results First Posted: January 31, 2022
• Last Update Posted: January 31, 2022
• Last Verified: February 2021

• 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