AISNCT05496361

A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke

A study testing Tianyi Revascularization Device and Solitaire FR Revascularization Device in people with AIS and Acute Ischemic Stroke, run by Suzhou Zenith Vascular SciTech Limited at 1 site in China.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: AIS, Acute Ischemic Stroke, Large Vessel Occlusion
What is being tested?: Tianyi Revascularization Device and Solitaire FR Revascularization Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 1 siteChina
Study dates: 24 Jan 2021to 20 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

aged 18-85 years
within 8 hours after symptom onset
The results showed that the scores of ASPECTS ≥6, 0<NIHSS<30 , and mRS <2 ;
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;
Signed informed consent.

Who cannot join

Clinical exclusion criteria:
Patients with epileptic seizure during stroke;
Patients with life expectancy less than 90 days;
Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;

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Patients with gastrointestinal or urinary tract bleeding in the past three weeks;
Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial;
Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases;
Patients with active bleeding or known bleeding tendency (INR>3.0 or platelet count<40*10^9/L or APTT>50 seconds);
The blood glucose which could not be controlled by drugs was less than 2.7 mmol/L or more than 22.2 mmol/L;
Patients with hypertension beyond the control of drugs (systolic blood pressure >180 mmHg, or diastolic blood pressure >105 mmHg);
Females who are pregnant or in lactation;
Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, antiplatelet drugs and nickel-titanium;
Patients who have undergone major surgical operations in the past month;
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
Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);
ASPECTS <6 points on head CT;
Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion;
DSA showed that bilateral carotid system was occluded at the same time;
DSA showed (or highly suspected) carotid dissection or arteritis;
DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover;
Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Changhai Hospital
Shanghai

Other trials in China

About this study

Official title: A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Read the detailed 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.

Conditions: AIS, Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
Being tested: Tianyi Revascularization Device, Solitaire FR Revascularization Device
Medical subject headings: Ischemic Stroke

What participants receive

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

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

Study groups in NCT05496361
Study group	Role	What they receive
Tianyi Revascularization Device	Experimental	Not described Receives: Device: Tianyi Revascularization Device
Solitaire FR Revascularization Device	Active comparator	Not described Receives: Device: Solitaire FR Revascularization Device

What is being measured

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

Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
Measured: At immediate post-procedure

Secondary outcomes (4)

Times to revascularization（From groin puncture to final revascularization result）
Measured: At immediate post-procedure
NIHSS score at 24h, 7-day or discharge
Measured: Within 24 hours，7-day or discharge post-procedure, whichever came first
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2
Measured: at 90 days post-procedure
Device Technical Success
Measured: At immediate post-procedure

Timeline

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

24 Jan 202120 Jul 2022

First posted11 Aug 2022
Study start24 Jan 2021
Primary completion24 Nov 2021
Study completion20 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AISStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05496361
Sponsor's protocol ID: CTP-301
Status last verified: Aug 2022
First submitted: 9 Aug 2022
Last updated: 11 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT05496361
Acronym / sponsor ID: CTP-301
Conditions: AIS, Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Suzhou Zenith Vascular SciTech LimitedIndustry (pharma, biotech, devices)
Study start: 24 Jan 2021 (actual)
Primary completion: 24 Nov 2021 (actual)
Study completion: 20 Jul 2022 (actual)
First posted: 11 Aug 2022 (actual)
Results: Not posted in the source record

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tianyi Revascularization Device	Experimental	Device: Tianyi Revascularization Device
Solitaire FR Revascularization Device	Active comparator	Device: Solitaire FR Revascularization Device

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

aged 18-85 years
within 8 hours after symptom onset
The results showed that the scores of ASPECTS ≥6, 0<NIHSS<30 , and mRS <2 ;
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;
Signed informed consent.

Key exclusion criteria (24 listed)

Patients with epileptic seizure during stroke;
Patients with life expectancy less than 90 days;
Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;

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

Primary outcome

Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
Time frame: At immediate post-procedure

4 secondary outcomes

Times to revascularization（From groin puncture to final revascularization result）
Time frame: At immediate post-procedure
NIHSS score at 24h, 7-day or discharge
Time frame: Within 24 hours，7-day or discharge post-procedure, whichever came first
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2
Time frame: at 90 days post-procedure
Device Technical Success
Time frame: At immediate post-procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
Individual participant dataSharing planned: No

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A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 24 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure (time frame: At immediate post-procedure). 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 NCT05496361.

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 11 Aug 2022.