The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Clopidogrel

Criteria

Inclusion Criteria:

1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months

2. Written informed consent from the subjects

3. Qualified candidates for coronary bypass surgery

4. Lesions with reference vessel diameter 2.75 to 3.5 mm

Exclusion Criteria:

1. Age ≤ 18 years

2. Cardiogenetic shock

3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%

4. Oral anticoagulation therapy

5. Known allergy or intolerance to the study medications

6. Malignancies and other comorbid conditions with a life expectancy less than 5 years

7. Subjects treated with both BRS and DES during the index procedure

8. Pregnant wowen

9. Planned staged PCI

10. Contemporaneous enrollment in a different clinical trial

11. Any revascularization within 1 year

12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment

13. Unprotected left main artery

14. Lesions located at the ostium of the main coronary artery

15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy