Status:
UNKNOWN
Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stenting
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Adverse Event
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This is a prospective single-center,randomized controlled trial,aiming to investigate the safety and efficacy of distal EPD in vertebral artery origin stenting(VAOS);256 subjects will be recruited in ...
Detailed Description
Ischemic cerebrovascular diseases are associated with a high rate of mortality and disability rate, as a consequence, many related trials were conducted to perfect prophylaxis and treatment of ischemi...
Eligibility Criteria
Inclusion
- Aged 40 to 80 years old;
- VAO atherosclerotic stenosis results in posterior circulation ischemic symptom refractory to best medical treatment;
- symptomatic VAO atherosclerotic stenosis\>70% evaluated by computed tomograph angiography(CTA) or Magnetic Resonance Angiography(MRA) or digital subtraction angiography(DSA);
- the diameter of the normal segment of the artery beyond the stenosis \>3.5mm;
- written informed consent.
Exclusion
- VAO stenosis is combined with ipsilateral vertebrobasilar disease including severe cranial vertebral artery stenosis and severe basilar artery stenosis.
- VAO is occluded;
- Patients who will be underwent bilateral VAOS due to bilateral VAO stenosis including someone with bilateral VAO stenosis \>70% and the patient who need contralateral VAOS after stenting in unilateral VAO due to recurrent posterior circulation ischemia refractory to best medical treatment.
- VAO stenosis caused by arteritis,artery dissection, aplasia, vasculopathy caused by radiotherapy etc, other than atherosclerosis;
- stroke within 30 days or myocardial infarction within 6 months;
- contraindication of anticoagulant and antiplatelet agents; allergy to iodinated contrast agent;
- severe comorbid diseases and intolerant to procedure; patient unlikely to cooperate with the procedure or provide informed consent.
- High risk of difficulty or failure in EPD advance and retrieval due to the tortuosity of the culprit vertebral artery origin.
Key Trial Info
Start Date :
May 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT03381534
Start Date
May 20 2017
End Date
July 1 2020
Last Update
December 27 2017
Active Locations (1)
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1
XuanWu hospital
Beijing, China