ClinicalTrials.gov
public full text
Public Domain
BioFreedom™ BA9™ Ultra
The purpose of the study is to assess the safety and efficacy of the BioFreedom Ultra stent for treatment of STEMI patients. Besides, in patients who are clinically indicated for a stage procedure, Investigators aim to assess the angiographic and endovascular healing of BioFreedom Ultra stent at one month This is a prospective, single center, post marketing registry. Investigators aim to recruit 50 patients. All enrolled patients will be followed up for 12 months. Restudy Subgroup For subjects who are clinically indicated for staged procedure, they will be recruited into restudy subgroup. Restudy angiogram of target lesion will be performed at 28 (±7) days. Intravascular OCT will be performed. The primary endpoint is target lesion failure (TLF) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC definitions) The co-primary endpoint in subjects who require stage procedure is stent strut coverage (degree of endothelialisation) as assessed by optic coherence tomography (OCT) at one month Secondary endpoints include 1. All-cause mortality 2. Cardiovascular death (cardiovascular and undetermined) 3. The composite of cardiovascular death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis at one year. 4. Stroke disabling and non-disabling ARC definition 5. Myocardial infarction 6. ARC Stent thrombosis 7. Clinically driven TLR at any follow-up time point 8. Clinically driven target vessel revascularization 9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month 10. Bleeding per BARC criteria For subjects in restudy subgroup 11. Restudy angiographic result (QCA) 12. OCT parameters including neointimal volume, neointimal area etc
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents#916913
- Biofreedom Stent in All Comer Population#862043
- Optical Coherence Tomography in Long Lesions#899534
- Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)#1031312
- A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES#876529
Record · ID 876390
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive