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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
drug (paclitaxel) coated balloon
Deviceuse drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis
PTA balloon
Deviceuse traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: DCB groupExperimental treatment 1 intervention
Group B: PTA groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Target vessel stroke or death event
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
Time frame
within 30 days post-procedureSecondary outcomes
1
device success rate
The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.
Time frame
assessed during procedure2
target vessel ischemia stroke event
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery
Time frame
between 31days and 12months post-procedure3
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
Time frame
between 31 days and 12 months post-procedure4
target vessel death event
Target-vessel related death 31 days to 12 months postoperatively
Time frame
between 31 days and 12 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Acotec Scientific Co., Ltd
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Source ClinicalTrials.gov