Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05496361
Other study ID # CTP-301
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2021
Est. completion date July 20, 2022

Study information

Verified date August 2022
Source Suzhou Zenith Vascular Scitech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.


Description:

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.


Recruitment information / eligibility

Status Completed
Enrollment 238
Est. completion date July 20, 2022
Est. primary completion date November 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. aged 18-85 years 2. within 8 hours after symptom onset 3. The results showed that the scores of ASPECTS =6, 0<NIHSS<30 , and mRS <2 ; 4. caused by a large vessel occlusion of the anterior circulation (internal carotid artery or the M1 and M2 segments of MCA and the A1 and A2 segments) cerebral artery confirmed by DSA; 5. Signed informed consent. Exclusion Criteria: Clinical exclusion criteria: 1. Patients with epileptic seizure during stroke; 2. Patients with life expectancy less than 90 days; 3. Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months; 4. Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment 5. Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months; 6. Patients with gastrointestinal or urinary tract bleeding in the past three weeks; 7. Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial; 8. Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases; 9. Patients with active bleeding or known bleeding tendency (INR>3.0 or platelet count<40*10^9/L or APTT>50 seconds); 10. The blood glucose which could not be controlled by drugs was less than 2.7 mmol/L or more than 22.2 mmol/L; 11. Patients with hypertension beyond the control of drugs (systolic blood pressure >180 mmHg, or diastolic blood pressure >105 mmHg); 12. Females who are pregnant or in lactation; 13. Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, antiplatelet drugs and nickel-titanium; 14. Patients who have undergone major surgical operations in the past month; 15. Other cases with unknown onset time or unsuitable for inclusion in the group judged by researchers;other conditions not suitable for inclusion judged by the researcher; Imaging exclusion criteria 1. Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator); 2. ASPECTS <6 points on head CT; 3. Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion; 4. DSA showed that bilateral carotid system was occluded at the same time; 5. DSA showed (or highly suspected) carotid dissection or arteritis; 6. DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover; 7. Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.

Study Design


Intervention

Device:
Tianyi Revascularization Device
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Solitaire FR Revascularization Device
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain

Locations

Country Name City State
China Shanghai Changhai Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Suzhou Zenith Vascular Scitech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours Within 24 hours post-procedure
Other All causes of mortality at 90 days at 90 days post-procedure
Other Occurrence of serious adverse events or adverse events related to device or procedure at 90 days post-procedure
Other Occurrence of device defect at 90 days post-procedure
Primary Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure At immediate post-procedure
Secondary Times to revascularization(From groin puncture to final revascularization result) At immediate post-procedure
Secondary NIHSS score at 24h, 7-day or discharge Within 24 hours,7-day or discharge post-procedure, whichever came first
Secondary Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2 at 90 days post-procedure
Secondary Device Technical Success At immediate post-procedure
See also
  Status Clinical Trial Phase
Recruiting NCT06113848 - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy Phase 3
Completed NCT04069546 - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency N/A
Active, not recruiting NCT05700097 - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy Phase 2
Recruiting NCT06058130 - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis N/A
Recruiting NCT04415164 - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke Phase 4
Recruiting NCT05363397 - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke Phase 2
Completed NCT05429658 - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System N/A
Recruiting NCT05390580 - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct N/A
Enrolling by invitation NCT05515393 - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke Phase 2
Active, not recruiting NCT05070260 - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo Phase 2/Phase 3
Terminated NCT05547412 - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed NCT03366818 - New Stent Retriever, VERSI System for AIS N/A
Not yet recruiting NCT06437431 - Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy Phase 2/Phase 3
Not yet recruiting NCT06040476 - Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS) Phase 2
Not yet recruiting NCT05293080 - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Phase 3
Completed NCT02223273 - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) N/A
Completed NCT02586233 - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke Phase 1/Phase 2
Terminated NCT01694381 - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor Early Phase 1
Not yet recruiting NCT01594190 - Physical Activity Immediately After Acute Cerebral Ischemia N/A
Completed NCT01120301 - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) Phase 3