Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

March 13, 2023 updated by: jizhong, Nanfang Hospital of Southern Medical University

Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis in Real-World Clinical Observations: a Prospective, Multicenter, Open-access, Single-arm Clinical Study

This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.

Study Type

Interventional

Enrollment (Anticipated)

144

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 Contact

Study Contact Backup

  • Name: Kaibin Huang
  • Phone Number: 15915751065

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years old, gender is not limited;
  2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;
  3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

  1. Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery;
  2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;
  3. Gastrointestinal disease with active bleeding;
  4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;
  5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
  6. Life expectancy less than 12 months;
  7. the investigator judged patients to be unsuitable for participation in this study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with vertebral atherosclerotic stenosis requiring stent implantation
Referring to "the 2015 Chinese Guidelines for Endovascular Interventional Treatment of Ischemic Cerebrovascular Disease", "the 2015 Symptomatic Atherosclerotic Sclerotic vertebral artery initiation stenosis: Chinese expert consensus" and "Subclavian/extracranial vertebral artery stenosis: Chinese expert consensus" in 2019 and other guidelines and expert consensus for the diagnosis of symptomatic vertebral artery atherosclerotic stenosis ≥ 50% and non-symptomatic vertebral artery atherosclerotic stenosis ≥ 70% in patients.
Device: The drug-eluting stent
Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of clinical ischemic events
Time Frame: within 1 year
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success Rate
Time Frame: within 1 year after surgery
Successful arrival and release of the stent in the target lesion with complete coverage of the lesion and residual stenosis <30%, no major adverse events (MAE).
within 1 year after surgery
Major adverse event (MAE) incidence
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.
1 month, 6 months, 12 months, 2 and 3 years
Incidence of bleeding events
Time Frame: 30 days and 1 year
Access or non access site bleeding
30 days and 1 year
Incidence of in-stent restenosis
Time Frame: within 1 year
Restenosis: in-stent stenosis rate ≥50% on imaging
within 1 year
Changes in the modified Rankin scale (mRS) scores
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
ability to perform daily living，mRS scores ranges 0-6 ， the more score the more severe outcome
1 month, 6 months, 12 months, 2 and 3 years
Change in NIHSS scores
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
NIHSS scores for neurological deficits
1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of major adverse events
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.
1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of restenosis
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Thrombosis in study stents
1 month, 6 months, 12 months, 2 and 3 years
Evaluation of clinical use for relative contraindications
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients
1 month, 6 months, 12 months, 2 and 3 years

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Zhong Ji, PHD, Nanfang Hospital of Southern 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 1, 2022

Primary Completion (Anticipated)

May 31, 2026

Study Completion (Anticipated)

May 31, 2029

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study is proceeding.

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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