Clinical Trials Logo

Clinical Trial Summary

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.


Clinical Trial Description

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial. - In the BIOSTEMI randomized controlled clinical trial, the Orsiro ultrathin-strut bio degradable polymer sirolimus-eluting stent was found superior to the best-in-class Xience thin-strut durable polymer everolimus-eluting stent with respect to target lesion failure at one-year follow-up among patients with STEMI undergoing primary PCI (Iglesias JF, et al., Lancet 2019). The difference was driven by a lower risk of clinically indicated target lesion revascularization with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent. - Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up. - As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years. - The long-term clinical benefits the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent over the Xience thin-strut durable polymer everolimus-eluting stent beyond the polymer degradation period remain uncertain. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05484310
Study type Observational
Source University Hospital, Geneva
Contact
Status Completed
Phase
Start date October 15, 2021
Completion date October 28, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A