Status:
NOT_YET_RECRUITING
The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pa...
Eligibility Criteria
Inclusion
- Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
- Written informed consent from the subjects
- Qualified candidates for coronary bypass surgery
- Lesions with reference vessel diameter 2.75 to 3.5 mm
Exclusion
- Age ≤ 18 years
- Cardiogenetic shock
- Chronic heart failure with a left ventricular ejection fraction ≤ 30%
- Oral anticoagulation therapy
- Known allergy or intolerance to the study medications
- Malignancies and other comorbid conditions with a life expectancy less than 5 years
- Subjects treated with both BRS and DES during the index procedure
- Pregnant wowen
- Planned staged PCI
- Contemporaneous enrollment in a different clinical trial
- Any revascularization within 1 year
- Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
- Unprotected left main artery
- Lesions located at the ostium of the main coronary artery
- bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
2106 Patients enrolled
Trial Details
Trial ID
NCT04501900
Start Date
October 1 2020
End Date
April 1 2026
Last Update
August 6 2020
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