Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05644314

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2023-03-14

144

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to observe the real-world effectiveness of a drug-eluting vertebral artery stenting system in treating atherosclerotic vertebral artery stenosis, a significant cause of ischemic strokes affecting the brain's posterior circulation. Stroke remains a leading cause of disability and death worldwide, with many strokes occurring in the vertebral arteries, which are crucial for brain blood flow. This study focuses on patients with symptomatic or non-symptomatic vertebral artery stenosis, evaluating the long-term impact of the treatment beyond previous clinical trials.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients prescribed medically with rapamycin drug-eluting vertebral artery stent systems
  • Patients and family members fully understand the trial's purpose, voluntarily participate, and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Unable to receive dual antiplatelet therapy due to known disease
  • Severe coagulation abnormalities
  • Severe infections that are not controlled
  • Severe systemic disease or uncontrollable hypertension
  • Contraindications for surgery
  • Presence of aneurysm that cannot be treated earlier or simultaneously or is unsuitable for surgery
  • Active gastrointestinal bleeding
  • Previous myocardial infarction or large-scale cerebral infarction within 2 weeks
  • Known contraindications to heparin, rapamycin, anesthesia, or contrast agents
  • Life expectancy less than 12 months
  • Investigator judged patients unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single procedure with follow-up

Participants receive the drug-eluting vertebral artery stent implantation as treatment for vertebral artery stenosis.

1 implantation visit (in-person)

Post-operative Follow-up

Duration - Up to 3 years

Participants are monitored to assess clinical success, adverse events, restenosis, and changes in neurological scores after stent implantation.

Visits at 1 month, 6 months, 12 months, 2 years, and 3 years

Trial Site Locations

Total: 1 location

1

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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Research Team

Z

Zhong Ji, PHD

K

Kaibin Huang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Trends in risk factors, patterns and causes in hospitalized strokes over 25 years: The Lausanne Stroke Registry.

Emmanuel Carrera, Malin Maeder-Ingvar, Andrea O Rossetti...

https://pubmed.ncbi.nlm.nih.gov/17519551

Incidence and prognosis of > or = 50% symptomatic vertebral or basilar artery stenosis: prospective population-based study.

L Marquardt, W Kuker, A Chandratheva...

https://pubmed.ncbi.nlm.nih.gov/19293244

Stroke risk after posterior circulation stroke/transient ischemic attack and its relationship to site of vertebrobasilar stenosis: pooled data analysis from prospective studies.

Giosue Gulli, Lars Marquardt, Peter M Rothwell...

https://pubmed.ncbi.nlm.nih.gov/23386676

Bare metal vs. drug-eluting stents for extracranial vertebral artery disease: a meta-analysis of nonrandomized comparative studies.

Nicolas Langwieser, Dominique Buyer, Tibor Schuster...

https://pubmed.ncbi.nlm.nih.gov/25290797