ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAcotec Scientific Co., Ltd
About this trial
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- drug (paclitaxel) coated balloon
- PTA balloon
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Acotec Scientific Co., Ltd
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Source ClinicalTrials.gov