ClinicalTrials.gov
public full text
Public Domain
Biofreedom Stent in All Comer Population
AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as the long-term clinical results in terms of safety and efficacy of the polymer-free DES technology in all comers patients with an indication to percutaneous coronary intervention. PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC classification (19). PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR). STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective observational registry aiming to enroll a population of 1000 patients. STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last patient in the registry. CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after the index procedure. PATIENTS SELECTION CRITERIA: This is an "all comers" registry and patient who will be enrolled have to meet the sequent criteria: * Patient must be at least 18 years of age at the time of signing the Informed Consent Form after Biofreedom placement. * All "de novo" lesion subsets are included. * Patient must agree to undergo all required follow-up visits and data collection. * Patient must have indication to percutaneous coronary intervention following: * Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or * Unstable angina / non ST-elevation myocardial infarction * ST-elevation myocardial infarction with de novo culprit lesion. EXCLUSION CRITERIA: The exclusion criteria must follow the most recent IFU which may include but are not limited to the following: * Known intolerance to any of the device components * In-stent restenosis * Woman with childbearing potentia
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
- Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study#1150869
- BioFreedom™ BA9™ Ultra#876390
- Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China#968121
- Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy#1074887
- REWARDS- In-stent Restenosis#1137992
Record · ID 862043
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