ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Intracranial Atherosclerosis
• Intervention / Treatment: Device: drug (paclitaxel) coated balloon; Device: PTA balloon

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Ma, MD; Phone Number: 010-59978585; Email: maning_03@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing TianTan Hospital
    • Contact: Ning Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB group; use drug (paclitaxel) coated balloon to treat intracranial in-stent restenosis	Device: drug (paclitaxel) coated balloon; use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis
Active Comparator: PTA group; use PTA balloon to treat intracranial in-stent restenosis	Device: PTA balloon; use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel stroke or death event	Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.	within 30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device success rate	The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.	assessed during procedure
target vessel ischemia stroke event	The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery	between 31days and 12months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events	Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure	between 31 days and 12 months post-procedure
target vessel death event	Target-vessel related death 31 days to 12 months postoperatively	between 31 days and 12 months post-procedure
National Institutes of Health Stroke Scale score	National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome)	at 12 months post-procedure
Modified Rankin Score score	Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome)	at 12 months post-procedure

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Ning Ma, MD, Beijing TianTan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: drug coated balloon; Intracranial Atherosclerosis; In-stent restenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: ACOART intracranial ISR pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No