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

NCT03381534 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-12-27

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Jiao Li Qun, MD · Xuanwu Hospital of Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-20
Primary Completion
2020-05-30
Completion
2020-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381534 on ClinicalTrials.gov