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

NCT04627870 | Recruiting

• 1 other identifier: ACOART intracranial ISR pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Atherosclerosis; Stroke

Keywords

Intracranial Atherosclerosis; In-stent restenosis; drug coated balloon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• device success rate

  assessed during procedure

• target vessel ischemia stroke event

  between 31days and 12months post-procedure

• Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events

  between 31 days and 12 months post-procedure

• target vessel death event

  between 31 days and 12 months post-procedure

• National Institutes of Health Stroke Scale score

  at 12 months post-procedure

Study Arms (2)

DCB group

EXPERIMENTAL

use drug (paclitaxel) coated balloon to treat intracranial in-stent restenosis

Device: drug (paclitaxel) coated balloon

PTA group

ACTIVE COMPARATOR

use PTA balloon to treat intracranial in-stent restenosis

Device: PTA balloon

Interventions

drug (paclitaxel) coated balloon DEVICE

use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis

DCB group

PTA balloon DEVICE

use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis

PTA group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Ning Ma, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Ma, MD

CONTACT

010-59978585; maning_03@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 13, 2020
• Study Start: May 26, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-06

Locations

CN (1)