Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study

NCT06683300 | Not Yet Recruiting

• 1 other identifier: KY2024-158-02
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China. Currently, there is no consensus regarding the duration of DAPT after drug-eluting stent treatment for vertebral artery stenosis(VAS). The objective of this study is to standardize clinical medication by shortening the duration of DAPT, thereby reducing the bleeding risk and medication burden for patients, while ensuring that there is no increase in ischemic events.

Conditions

Vertebral Artery Stenosis

Keywords

vertebral artery stent; dual antiplatelet duration; symptomatic vertebral artery atherosclerotic stenosis

Outcome Measures

Primary Outcomes (1)

• Occurrence of ischemic stroke in the territory of the target artery within 1 year

  The primary endpoint was defined as occurrence of ischemic stroke events in the target arterial territory, excluding transient ischemic attacks.

  12 months after stent implantation

Secondary Outcomes (10)

• Occurrence of Periprocedural events

  within 30 days after stent implantation

• Occurrence of Bleeding Events within 1 year

  12 months after stent implantation

• Occurrence of TIA events related to the target territory within 1 year

  12 months after stent implantation

• Occurrence of disabling and fatal stroke events within 1 year

  12 months after stent implantation

• AEs and SAEs

  in 12 months

Study Arms (1)

3 months DAPT

dual antiplatelet therapy (DAPT) for 3 months

Drug: DAPT for 3 months after vertebral artery stenting

Interventions

DAPT for 3 months after vertebral artery stenting DRUG

After implantation of a drug-eluting stent in the vertebral artery, dual antiplatelet therapy (DAPT) were administered for 3 months. The types of antiplatelet medications are not limited, with the standard regimen consisting of aspirin 100 mg once daily combined with either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily. Additional antiplatelet agents such as indobufen may also be considered acceptable.

3 months DAPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents.

You may qualify if:

• Age ≥18 years old, gender unlimited;
• Based on clinical and imaging evidence, the investigators identified patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents;
• Patients or their guardians sign informed consent.

You may not qualify if:

• Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;
• Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;
• Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;
• Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;
• Interventional or surgical procedures are planned within 90 days;
• Known contraindications to heparin, rapamycin, anesthesia and contrast agents;
• Life expectancy is less than 12 months;
• The researcher considers it inappropriate to participate in this study.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Vertebrobasilar Insufficiency

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Baixue Jia, MD

CONTACT

+86-15010125093; beckyberry@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)