A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic… (NCT04949880) | Clinical Trial Compass
UnknownNot Applicable
A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis
China132 participantsStarted 2021-11-02
Plain-language summary
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 80 years, any gender;
* Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography;
* The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment);
* Intracranial artery stenosis requiring interventional treatment is a single lesion;
* Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age\>45;
* modified Rankin Scale(mRS) score≤2 before enrollment;
* Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent.
Exclusion Criteria:
* History of acute ischemic stroke within 2 weeks;
* History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months;
* Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously);
* Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation;
* The length of intracranial artery stenosis \>10mm and extremely angulated \>90°, which indicated by angiography;
* History of stent intervention within the target lesion;
* Allergic to heparin, sirolimus (i.e. rapamycin), contrast…