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

December 25, 2017 updated by: lingfeng, Xuanwu Hospital, Beijing

Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stent Angioplasty :A Prospective, Multicenter, Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 ischemic stroke. 2/3 of cerebral blood supply is offered by Internal carotid artery(ICA) , due to high morbility and disability rate of carotid territory stroke, stoke caused by ICA stenosis is always emphasized by authors. With the development to the depth in this field, ischemic stroke in posterior circulation related to vertebral artery stenosis is gradually paid attention recently. Outcome from New England medical center posterior circulation registry study revealed that 20% of patients were found to have vertebral artery origin(VAO) stenosis, in 9% of these patients, no other cause of stroke was identified. The relative risk of having a stroke or dying in patients with VAO stenosis was 6 times than that of patients without VAO stenosis. Therefore, VAO stenosis need appropriate management to prevent potentiality of ischemic stroke.

Nowadays there are three treatment alternatives for extracranial VAO stenosis: medicine, surgery and endovascular stent angioplasty. However, medical therapy mainly focus on prevention and delay of severe ischemic events other than radical therapy, and it's not always effective to improve symptoms of posterior circulation ischemia. Surgery are limited by its serious trauma and the combined postoperative morbidity and mortality rates ranging from 10% to 20%.Endovascular stent angioplasty was feasible in ICA stenosis as reported in literatures, and that promotes the utilization of stent in VAO stenosis in recent years. Related retrospective studies have demonstrated the safety and efficacy of vertebral artery origin stenting(VAOS) in VAO stenosis. In a Meta analysis that summarized 27 articles about extracranial vertebral artery stenting, Stayman observed that the rate of transient ischemic attack(TIA) and stroke within postprocedural 30 days was 1.1% and 0.8% respectively. Compter etc. are conducting a prospective case-control study to assess the safety and feasibility of VAOS, which final outcome is thought to be relatively authentic.

However, some drawbacks in VAOS needs additional resolution, like embolization caused by plaque debris, high restenosis rate, vasospasm, vessel dissection. Especially, embolization is associated with not only plaque characteristic, but also anatomy of the vertebral arteries, which is potentially essential to high risk of plaque debris dislodgment. The origin of vertebral artery is characterized with small diameter and tortuous course. Dodevski analyzed 30 patients' vertebral arteries and found that 40% of patients' vertebral artery was tortuous, the diameter of the VAO on the left side was in the range between 1.60-5.2 mm, mean 3.33 ± 0.89 mm, and on the right side from 1.64-5.40 mm, mean 3.19 ± 0.98 mm. Tortuosity and small diameter in VAO will increase operation difficulty and procedural time. Borhanisummarized 27 articles focusing on vertebral origin angioplasty and concluded that of the 808 patients underwent stent angioplasty, the combined rate of stroke and TIA within 1 month after stenting was 6.9%.

Concerning dislodgement of plaque debris, embolic protection device(EPD) is applied recently to decrease the risk of embolization. But utilization of EPD in VAOS is mainly based on its safety and feasibility in carotid artery stenting(CAS). In CAS, cerebral embolic protection devices can effectively reduce the incidence of transient ischemic attack, stroke and other related adverse events. The U.S. Safety Committee recommended stopping unprotected CAS, because the 30-day rate of stroke was 3.9 times higher than that of CAS with cerebral protection. However, VAOS is different from CAS, and its performance in CAS cann't serve as medical science evidence for distal EPD in VAOS. Firstly, the rate of postoperative restenosis after VAOS is higher than that of CAS, ranging from 20% to 66.7%.Secondly, VAO are characterized by concentric, fibrous, and smooth lesions with lower incidence of ulceration and intraluminal hemorrhage compared with extracranial carotid artery circulation[13]. Thirdly, the microscopic structure of VAO is featured with elastic fibers and smooth muscles. These distinctions indicate that investigators should make a distinction between CAS and VAOS in terms of intravascular intervention. As to the use of EPD in VAOS, no Class Ⅰ evidence can verify the safety and efficacy of EPD and clinicians share discrepant opinions. Some authors thought that distal protection devices will suspend operation process, increase operation-related risk and may cause embolization during crossing lesion and retrieval which may be referable to transient shear stress. In addition, some patients are intolerable to flow cessation caused by distal EPD. Moreover, foreign case reports even noted that utilization of distal EPD was probable to induce vasospasm and difficult retrieval of distal EPD was finally managed by secondary surgery in some cases[14, 15]. However, small sample-size studies demonstrated it's safe and feasible to use distal EPD in VAOS. Qureshi etc.retrospectively analyzed clinical data of 12 patients underwent VAOS with filter protection, outcome revealed that no stroke and death events occured within 1 month follow-up. In a multicenter study, Edgell etc. contrastively analyzed the data of patients underwent VAOS with and without distal EPD, the rate of TIA and stroke within 1 month between the two groups showed no significant difference. Divani etc. analyzed plaque debris captured by EPDs in 14 patients who underwent VAOS with distal protection devices, the outcome revealed that relative to the size of the filter, the proportion of captured debris ranged from 0.1% to 22% in the VA filters, hence, Divani recommended the use of distal EPD in VAOS.

In summary, the use of distal EPD in VAOS is debatable, no class I evidence can support the advantage of use of distal EPD in VAOS. Here, the investigators will conduct this prospective, single-center, randomize controlled trial aiming to analyzed the safety and efficacy of distal EPD in VAOS.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital
        • Contact:
          • cheng lei, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days after procedure
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
1 month after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Jiao Li Qun, MD, Xuanwu Hospital of Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2017

Primary Completion (ANTICIPATED)

May 30, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (ACTUAL)

December 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 25, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XuanwuH-VAO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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