Clinical trial NCT04627870: ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
Official title: A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Atherosclerosis
Stroke
Keywords: Intracranial Atherosclerosis
In-stent restenosis
drug coated balloon
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2020-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.

Detailed description: This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as \>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss
* presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
* asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score \<3 on DSA.
* the diameter of target vessel is 2.0-4.5mm
* there is only one intracranial ISR lesion per subject
* baseline mRS score ≤2
* Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

* Patients with stroke within 2 weeks before procedure;
* any history of brain parenchyma or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days.
* Those who have received thrombolysis within 24 hours before procedure;
* Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline)
* patients with thrombus in target vessels.
* in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.
* Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.
* patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.
* Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.
* Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;
* patients with myocardial infarction within 6 weeks before procedure.
* those who cannot tolerate general anesthesia due to insufficiency of heart, lung and other important organs.
* patients with known severe hepatic and renal dysfunction.
* patients with hemoglobin \< 100g / L, platelet count \< 100,000 / mm3, INR \> 1.5or with uncorrectable factors leading to bleeding.
* patients who cannot receive dual antiplatelet therapy due to existing diseases or who are tested to be tolerant to dual antiplatelet therapy.
* Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs
* current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg).
* Life expectancy \< 1 year.
* pregnant or lactating women.
* patients who are unable to complete follow-up due to cognitive, emotional disorders or mental illness.
* Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programme;
* According to the judgement of the investigator, other situations that are not suitable for enrollment

Primary outcomes:
measure: Target vessel stroke or death event
timeFrame: within 30 days post-procedure
Secondary outcomes:
measure: device success rate
timeFrame: assessed during procedure
measure: target vessel ischemia stroke event
timeFrame: between 31days and 12months post-procedure
measure: Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
timeFrame: between 31 days and 12 months post-procedure
measure: target vessel death event
timeFrame: between 31 days and 12 months post-procedure
measure: National Institutes of Health Stroke Scale score
timeFrame: at 12 months post-procedure
measure: Modified Rankin Score score
timeFrame: at 12 months post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ning Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: