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Tests treatment safety and results for Intracranial Atherosclerosis
Official title The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
ClinicalTrials.gov ID: NCT05757505
What this study is testing
- What it's testing
- The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75;
- people with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral...
- The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks;
- The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral...
- Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm;
You likely can't join if
- Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis...
- Preoperative MRI shows only perforator infarction in the target lesion;
- Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid...
- Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target...
- There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target...
- people have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure;
See the full eligibility criteria
- Age 18-75;
- people with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral circulation and hypoperfusion in the offending vessel blood supply;
- The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks;
- The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of vertebral artery and the basilar...
- Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm;
- Stenosis degree of intracranial arteries≥70% and ≤99% measured by intracranial angiography (WASID method);
- Intracranial artery stenosis which requiring treatment treatment is a single lesion;
- people have at least 1 atherosclerotic plaque risk factor including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history;
- mRS≤2 before enrollment;
- Voluntarily participate in this study and sign the informed consent form, can complete examinations and follow-ups in accordance with the requirements of the protocol during the clinical trial.
- Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.;
- Preoperative MRI shows only perforator infarction in the target lesion;
- Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the...
- Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position;
- There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions;
- people have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure;
- Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms;
- The target lesion has a history of stent implantation;
- It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy;
- There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days;
- people with an INR \> 1.5 or the presence of nonmodifiable bleeding factors;
- Medically uncontrolled severe hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg);
- Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine \>3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST \>3 times normal)...
- Life expectancy is less than two years;
- Women who are pregnant or breastfeeding;
- people unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness;
- people who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint;
- Other circumstances which investigators do not consider are appropriate for intracranial stent treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Baotou, Neimenggu, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Nanchang, Jiangxi, China; Changchun, Jilin, China; Dalian, Liaoning, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.