DEB for Symptomatic Intracranial Atherosclerosis Stenosis

NCT04821726 | Unknown

• 1 other identifier: LNYY2020001
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Ischemia; Cerebral Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Restenosis

  Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss.

  6 months (+60 days)

Secondary Outcomes (11)

• Angiographic success rate

  immediately after procedure

• The success rate of device

  immediately after procedure

• The success rate of procedure

  In-hospital (Maximum 7 days after procedure)

• Target lesion stenosis

  6 months (+60 days) and 12 months (±60 days)

• Restenosis

  12 months (±60 days)

Study Arms (1)

Drug eluting balloon (Vmoky)

EXPERIMENTAL

A paclitaxel eluting balloon produced by Yinyi (Liaoning) Biotech Co., Ltd. Balloon length: 8-40 mm, diameter：1.25-5.00 mm.

Device: Drug eluting balloon (Vmoky)

Interventions

Drug eluting balloon (Vmoky) DEVICE

Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis

Drug eluting balloon (Vmoky)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• mRS≤3 points；
• Patients or their guardians are able to understand the purpose of the trial, voluntarily participate in and sign a written informed consent form, and receive follow-up visits from patients.

You may not qualify if:

• 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；
• Uncontrollable hypertension by medication (Systolic pressure≥ystolic pres diastolic blood pressure≥pressurec；
• Severe combined or unstable conditions, such as severe heart failure, lung failure or kidney failure (serum creatinine\>3.0mg/dL (264 μmol/L) or renal cyspheric filtration rate (GFR) \<30ml/min), severe liver insequencies, malignant tumors;
• A history of gastrointestinal haemorrhage or haemorrhagic disease (e.g. idiopathic platelet reduction cyanosis, etc.) or a history of bleeding tendencies within 6 months prior to the signing of the informed consent；
• Hemoglobin is below 90g/L, plateplates\<90×109/L；
• The International Standardized Rate (INR) \>1.5, with unreal corrective bleeding factors；
• Can not carry out antiplatelet/anticoagulant treatment, with anaesthetic and contrast agent contraindication;
• The angiography shows that the vascular path is curly, and the device is difficult to reach the target position or to withdraw；

Sponsors & Collaborators

• Yinyi(Liaoning) Biotech Co., Ltd.: lead
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Brain Ischemia; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Tianxiao Li

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 29, 2021
• Study Start: June 21, 2021
• Primary Completion: August 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)