Trevo® Retriever Registry (China)

NCT03554850 | Completed Results FDA Device

• 1 other identifier: CDM10001400
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 10

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.

Conditions

Real World Data in China

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Day 90 mRS

  Day 90

• Day 90 Mortality

  Day 90

• Neurological Deterioration

  24 hours

• Rate of Study Device and Procedure Related SAE Through Day 90

  Day 90

Interventions

Trevo® Retriever DEVICE

Stent retriever procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Populations met the inclusion/exclusion criteria above

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (10)

Beijing TianTan Hospital

Beijing, Beijing Municipality, 100050, China

Location

The Hospital of Shunyi District Beijing

Beijing, Beijing Municipality, 101300, China

Location

Qingyuan City People's Hospital

Qingyuan, Guangdong, 511518, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

Location

Linyi People's Hospital

Linyi, Shandong, 276003, China

Location

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Wenzhou Central Hospital

Wenzhou, Zhejiang, 325000, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Results Point of Contact

• Title: Fei Qin
• Organization: Stryker Neurovascular

fei.qin@stryker.com

+8613524821775

Study Officials

• ZhongRong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 13, 2018
• Study Start: January 30, 2019
• Primary Completion: September 8, 2020
• Study Completion: February 2, 2021
• Last Updated: May 27, 2022
• Results First Posted: January 31, 2022

Record last verified: 2022-05

Locations

CN (10)