Clinical trial NCT06683300: Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
Official title: Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vertebral Artery Stenosis
Keywords: vertebral artery stent
dual antiplatelet duration
symptomatic vertebral artery atherosclerotic stenosis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Occurrence of ischemic stroke in the territory of the target artery within 1 year
timeFrame: 12 months after stent implantation
Secondary outcomes:
measure: Occurrence of Periprocedural events
timeFrame: within 30 days after stent implantation
measure: Occurrence of Bleeding Events within 1 year
timeFrame: 12 months after stent implantation
measure: Occurrence of TIA events related to the target territory within 1 year
timeFrame: 12 months after stent implantation
measure: Occurrence of disabling and fatal stroke events within 1 year
timeFrame: 12 months after stent implantation
measure: AEs and SAEs
timeFrame: in 12 months
measure: Occurrence of residual stenosis after the procedure
timeFrame: At the end of the procedure
measure: Rate of In-stent restenosis (ISR) within 12 months
timeFrame: 12 months after stent implantation
measure: modified Rankin Scale score at 1 year
timeFrame: 12 months after stent implantation
measure: The National Institutes of Health Stroke Scale (NIHSS) score at 1 year
timeFrame: 12 months after stent implantation
measure: EQ-5D score at 1 year
timeFrame: 12 months after stent implantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: