drugset / Trial / NCT03952273
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
Active not recruiting
3141 enrolled
Phillip Freeman
Aarhus University Hospital · collabBiosensors International · collabOdense University Hospital · collabOrbusNeich · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
Timeline
- Start
- 2019-08-14
- Primary completion
- 2023-03-19
- Completion
- 2030-11-30
Outcome
Met primary endpoint
paper BES was noninferior to DTS at 1-year follow-up regarding the primary endpoint of TLF. PMID 40406942 ↗
paper risk difference: -1.07% (upper limit of 1-sided 90% CI: 0.21%), (P for noninferiority = 0.00002) PMID 40406942 ↗
Publications
- Eftekhari A, Jensen LO, Veien K, Raungaard B, Rasmussen JG, Maeng M, Terkelsen CJ, Ellert-Gregersen J, Stottrup NB, Lassen JF, Hansen HS, Thim T, Jensen RV, Nielsen R, Jensen SE, Kristensen SD, Hougaard M, Junker A, Christensen MK, Aaroe J, Froslev T, Jakobsen L, Christiansen EH. Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial. J Am Coll Cardiol. 2025 Jul 15;86(2):106-115. doi: 10.1016/j.jacc.2025.05.012. Epub 2025 May 21.
- Eftekhari A, Christiansen EH, Lassen JF, Raungaard B, Jakobsen L, Jensen LO. Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial. Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | — | — |
| Subject | UMIROLIMUS | Small molecule | — | — |