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

NCT ID: NCT06683300

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-12-31

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.

Detailed Description

As the drug-eluting stents (DES) with indications for vertebral artery treatment have been officially approved in China, DES has gradually been widely used in the treatment of vertebral artery stenosis. There is increasing clinical attention towards the duration of dual antiplatelet therapy (DAPT) following stenting.

Currently, there is limited evidence regarding the optimal DAPT duration following endovascular treatment for vertebral artery stenosis. Therefore, clinical practice typically relies on experiences derived from treatments for coronary, carotid, or lower limb artery diseases, with a conventional recommendation of 6 to 12 months of antiplatelet therapy post-stent implantation.

Evidence obtained from coronary stents shows that the short-term DAPT strategy of 1-3 months after PCI in the new generation of DES can significantly reduce the incidence of severe bleeding without increasing ischemic events compared with the standard DAPT strategy of 7-12 months, especially for non-acute elective surgery patients who are similar to those with vertebral artery stenosis stents.

This study employs new-generation Co-Cr fluoropolymer DES to evaluate the balance between ischemic and bleeding complications by shortening the DAPT duration, with the ultimate aim of maximizing patient benefits.

Conditions

Vertebral Artery Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

3 months DAPT

dual antiplatelet therapy (DAPT) for 3 months

DAPT for 3 months after vertebral artery stenting

Intervention Type: 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.

Interventions

DAPT for 3 months after vertebral artery stenting

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, gender unlimited;

2. 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;

3. Patients or their guardians sign informed consent.

Exclusion Criteria

1. Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;

2. Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;

3. Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;

4. Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;

5. Interventional or surgical procedures are planned within 90 days;

6. Known contraindications to heparin, rapamycin, anesthesia and contrast agents;

7. Life expectancy is less than 12 months;

8. The researcher considers it inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Central Contacts

Baixue Jia, MD

Role: CONTACT

beckyberry@163.com

+86-15010125093

Facility Contacts

Baixue Jia, MD

Role: primary

beckyberry@163.com

+86-15010125093

Other Identifiers

KY2024-158-02

Identifier Type: -

Identifier Source: org_study_id