ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis (NCT04627870) | Clinical Trial Compass
RecruitingNot Applicable
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
China20 participantsStarted 2021-05-26
Plain-language summary
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 procedur…