Randomized Clinical Comparison of a Combined Sirolimus Eluting and Endothelial Progenitor Cell COMBO Stent With a Sirolimus-eluting OSIRO Stent in Patients Treated With Percutaneous Coronary Intervention - The SORT-OUT X Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,148
- Locations
- 8
- Primary Endpoint
- Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
Study Overview
Brief Summary
The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.
Detailed Description
Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
- •The patients will be treated in accordance with the criteria applicable at the individual sites.
- •The investigators plan to include 3,140 patients.
Exclusion Criteria
- •Age < 18 years
- •The patient does not wish to participate
- •The patient is not able to consent to randomization (eg intubated patients)
- •The patient do not speak Danish
- •The patient is already included in this study
- •The patient is already participating in other stent studies
- •Life expectancy <1 year
- •Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
- •Allergic to sirolimus
Outcomes
Primary Outcomes
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
Time Frame: Within 12 months
Analysing the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the OsiroTM stent will be used as the reference group
Target Lesion Revascularisation (TLR)
Time Frame: Within 12 months
Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90). TLR will be clinically driven.
Secondary Outcomes
- Cardiac death(Through 5 years)
- All death(Through 5 years)
- Individual components of the primary end point comprise the secondary end points(Clinical follow-up will be continued through 5 years)
- Stent thrombosis(Through 5 years)
- Clinically indicated TLR(Through 5 years)
- TVR(Through 5 years)
- MI(Through 5 years)
- Patient-related composite end point(Through 5 years)
Investigators
Lars Jakobsen
MD
Aarhus University Hospital Skejby