AcoArt VI / Vertebral Artery Ostium Stenosis in China (NCT03910166) | Clinical Trial Compass
CompletedNot Applicable
AcoArt VI / Vertebral Artery Ostium Stenosis in China
China180 participantsStarted 2020-01-06
Plain-language summary
The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
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:
* aged between 18 and 80 years old
* symptomatic VAO stenosis refractory to AMM (aggressive medical management)
* etiology of VAOS was atherosclerosis
* the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
* Target lesion has stenosis ≥ 70% evidenced by angiography
* Score on the modified Rankin scale ≤ 3
* NIHSS≤ 6
* Patients have signed informed consent
Exclusion Criteria:
* In-stent restenosis in vertebral artery
* Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
* Tortuous or variable vessels
* distal serial stenosis or distal vascular dysplasia of the stenosis segment
* Non-atherosclerotic arterial stenosis
* Non-vertebral artery stenosis caused TIA or stroke
* intracranial stent implantation within 12 months
* Intracranial hemorrhage occurred within 3 months
* Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure
* Active bleeding or coagulation disorders
* Serious liver/kidney damage, not suitable for routine surgical treatment
* Myocardial infarction or extensive cerebral infarction occurred within 2 weeks
* Uncontrolled high blood pressure
* Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm
* Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc
* Life expectancy shorter than 1…