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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627870
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Acotec Scientific Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Atherosclerosis Stroke Device: drug (paclitaxel) coated balloon Device: PTA balloon Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Paclitaxel

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Target vessel stroke or death event [ Time Frame: within 30 days post-procedure ]
    Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.


Secondary Outcome Measures :
  1. device success rate [ Time Frame: assessed during procedure ]
    The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.

  2. target vessel ischemia stroke event [ Time Frame: between 31days and 12months post-procedure ]
    The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery

  3. Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events [ Time Frame: between 31 days and 12 months post-procedure ]
    Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure

  4. target vessel death event [ Time Frame: between 31 days and 12 months post-procedure ]
    Target-vessel related death 31 days to 12 months postoperatively

  5. National Institutes of Health Stroke Scale score [ Time Frame: at 12 months post-procedure ]
    National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome)

  6. Modified Rankin Score score [ Time Frame: at 12 months post-procedure ]
    Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627870


Contacts
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Contact: Ning Ma, MD 13581889908 maning_03@hotmail.com

Locations
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China
Beijing Tiantan Hospital Recruiting
Beijing, China
Contact: Ning Ma, MD         
Sponsors and Collaborators
Acotec Scientific Co., Ltd
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Ning Ma, MD Beijing Tiantan Hospital
More Information
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Responsible Party: Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier: NCT04627870    
Other Study ID Numbers: ACOART intracranial ISR pilot
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acotec Scientific Co., Ltd:
Intracranial Atherosclerosis
In-stent restenosis
drug coated balloon
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action