UnknownNot Applicable

DEB for Symptomatic Intracranial Atherosclerosis Stenosis

China155 participantsStarted 2021-06-21

Plain-language summary

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18 to 80 years old；
✓. Symptomatic intracranial artery stenosis, the degree of intracranial diseased artery vascular stenosis measured under cerebral angiography between 70\~99% (WASID method)；
✓. Symptoms are still recurrent after conservative medication (symptoms refer to stroke and transient ischemic episodes of the brain)，or intracranial artery stenosis combined with remote low perfusion performance (rCBF or rCBV abnormalities) in patients.
✓. The stenotic vessels are located in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, distal blood vessels are normal；
✓. Only one lesion needed to be treated；
✓. The intracranial artery needed to be treated l art mm in diameter；
✓. Pre-expansion must be satisfied: forward blood flow TICI 3 level, pre-expanded guide wire retention, observation for 5 minutes, residual stenosis is still ≤50%; without blood limited dissection；
✓. Patients have at least 1 porridge plaque risk factor, including past or existing hypertension, diabetes, hyperlipidemia, smoking;

Exclusion criteria

✕. Target lesion is in-stent restenosis；
✕. Exist lesion stenosis more than 50% out of the target vessel；
✕. Intracranial haemorrhage occurred within 3 months (substantial cerebral hemorrhage, large amount of subcranial hemorrhage, subdural/external bleeding)；
✕. Acute ischemic stroke has occurred in the last two weeks；
✕. Stenosis caused by non-atherosclerosis: e.g. arterial mezzanine, moya-moya disease, vasculitis, radioactive vascular disease or fibrous muscle dysplasia;
✕. Severe calcified, angulate and Mori type C lesions, as well as congenital development of thin blood vessels and fenestration；
✕. Combine intracranial tumors, aneurysms, or intracranial venous malformations；
✕. There are risk factors that can lead to cardiogenic embolism: fibrillation, left-ventricle thrombosis, mycardial infarction within 6 weeks, etc；

What they're measuring

Restenosis

Timeframe: 6 months (+60 days)

Trial details

NCT IDNCT04821726

SponsorYinyi(Liaoning) Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-30

View on ClinicalTrials.gov More Cerebral Ischemia trials