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

NCT03381534 | Unknown DMC

• 1 other identifier: XuanwuH-VAO
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Event

Keywords

vertebral artery origin; angioplasty; distal embolic protection

Outcome Measures

Primary Outcomes (1)

• embolus capture rate in patients treated with VAO stenting with EPD

  embolus capture rate is calculate by number of patients with embolus in EPD divided number of patients without embolus in EPD in EPD group

  during procedure

Secondary Outcomes (2)

• incidence of ischemic stroke in the two group

  30 days after procedure

• incidence of disable or fatal ischemic stroke in EPD group

  1 month after procedure

Study Arms (2)

stent assisted angioplasty

PLACEBO COMPARATOR

patient randomly assigned to this group would be undergone stenting of vertebral artery origin without embolic protection device

Device: stent assisted angioplasty

stenting with EPD

EXPERIMENTAL

patient randomly assigned to this group would be undergone stenting of vertebral artery origin with embolic protection device

Device: stenting with EPD

Interventions

stenting with EPD DEVICE

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

stenting with EPD

stent assisted angioplasty DEVICE

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

stent assisted angioplasty

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

XuanWu hospital

Beijing, China

RECRUITING

Related Publications (19)

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MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jiao Li Qun, MD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cheng lei, master

CONTACT

13718690026; chenglei1865@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of neurosurgery department of Xuanwu hospital

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: December 22, 2017
• Study Start: May 20, 2017
• Primary Completion: May 30, 2020
• Study Completion: July 1, 2020
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)