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Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stenting

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ClinicalTrials.gov Identifier: NCT03381534
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
lingfeng, Xuanwu Hospital, Beijing

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 this study,after randomized recruitment, treatment group(128 subjects each group) undergo VAOS with adjuvant distal embolic protection device(EPD),control group undergo routine VAOS without distal embolic protection device.Intraprocedural and postprocedural in-hospital adverse events,including stroke,death and dis-retrieval of EPD,will be noted and cost-effectiveness analysis also will be conduct,including economic cost,hospital stays.

Condition or disease Intervention/treatment Phase
Adverse Event Device: stenting with EPD Device: stent assisted angioplasty Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stent Angioplasty :A Prospective, Multicenter, Randomized Controlled Trial
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Placebo Comparator: stent assisted angioplasty
patient randomly assigned to this group would be undergone stenting of vertebral artery origin without embolic protection device
Device: stent assisted angioplasty
participants will be randomly assigned to control group or experimental group,patients in control group will be undergone stenting of vertebral artery origin without embolic protection device,patient in experimental group will be undergone stenting of vertebral artery origin with embolic protection device

Experimental: stenting with EPD
patient randomly assigned to this group would be undergone stenting of vertebral artery origin with embolic protection device
Device: stenting with EPD
participants will be randomly assigned to control group or experimental group,patients in control group will be undergone stenting of vertebral artery origin without embolic protection device,patient in experimental group will be undergone stenting of vertebral artery origin with embolic protection device




Primary Outcome Measures :
  1. embolus capture rate in patients treated with VAO stenting with EPD [ Time Frame: during procedure ]
    embolus capture rate is calculate by number of patients with embolus in EPD divided number of patients without embolus in EPD in EPD group


Secondary Outcome Measures :
  1. incidence of ischemic stroke in the two group [ Time Frame: 30 days after procedure ]
    number of patients with or without ischemic stroke in posterior circulationcirculation territory will be collected in EPD group

  2. incidence of disable or fatal ischemic stroke in EPD group [ Time Frame: 1 month after procedure ]
    number of patients who present disable of fatal ischemic stroke in posterior



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 40 to 80 years old;
  2. VAO atherosclerotic stenosis results in posterior circulation ischemic symptom refractory to best medical treatment;
  3. symptomatic VAO atherosclerotic stenosis>70% evaluated by computed tomograph angiography(CTA) or Magnetic Resonance Angiography(MRA) or digital subtraction angiography(DSA);
  4. the diameter of the normal segment of the artery beyond the stenosis >3.5mm;
  5. written informed consent.

Exclusion Criteria:

  1. VAO stenosis is combined with ipsilateral vertebrobasilar disease including severe cranial vertebral artery stenosis and severe basilar artery stenosis.
  2. VAO is occluded;
  3. 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.
  4. VAO stenosis caused by arteritis,artery dissection, aplasia, vasculopathy caused by radiotherapy etc, other than atherosclerosis;
  5. stroke within 30 days or myocardial infarction within 6 months;
  6. contraindication of anticoagulant and antiplatelet agents; allergy to iodinated contrast agent;
  7. severe comorbid diseases and intolerant to procedure; patient unlikely to cooperate with the procedure or provide informed consent.
  8. High risk of difficulty or failure in EPD advance and retrieval due to the tortuosity of the culprit vertebral artery origin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381534


Contacts
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Contact: cheng lei, master 13718690026 chenglei1865@126.com

Locations
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China
XuanWu hospital Recruiting
Beijing, China
Contact: cheng lei, master         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Jiao Li Qun, MD Xuanwu Hospital of Capital Medical University

Publications of Results:

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Responsible Party: lingfeng, director of neurosurgery department of Xuanwu hospital, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03381534     History of Changes
Other Study ID Numbers: XuanwuH-VAO
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by lingfeng, Xuanwu Hospital, Beijing:
vertebral artery origin
angioplasty
distal embolic protection