An observational study in Coronary Self Expanding Stent, sponsored by Stentys. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by Stentys · Observational
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S stent used in routine clinical practice. Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for elective percutaneous coronary interventions suitable for a self-expanding stent, can be included in the registry.
This registry will allow collecting data, and provide substantial information in a real world setting on patients with indications like lesions in vessels with diameter variance, large vessels, left main coronary artery, bifurcations, ectatic vessels, ...
WIN will enroll 750 patients from approximately 30 sites.
Stentys is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for Percutaneous Coronary Interventions suitable for a self-expanding drug eluting stent. Patient must be over legal age, and sign an authorization form for collection, transfer and processing of personal data.
Exclusion Criteria:
Known pregnancy or breastfeeding; 2. Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
PCI
TLF at 1 Year follow-up
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR)
Time frame: 1 year follow-up post-procedure
TLF at 2 Year
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion
Time frame: 2 year follow-up post-procedure
TVF at 1 Year
Target Vessel Failure (TVF) defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically indicated Target Vessel Revascularization (TVR),
Time frame: 1 year follow-up post-procedure
Acute success rates
1. Device Success: Attainment of \< 20% final in-stent residual stenosis of the target lesion with the XPOSITION S; 2. Lesion Success: Attainment of \< 20% final in-stent residual stenosis of the target lesion using any percutaneous method; 3. Procedure Success: TIMI grade 3 and no in-hospital MACE
Time frame: From Index procedure up to hospital discharge (48 hours post procedure)
Stent thrombosis
Stent thrombosis (definite/probable) - Academic Research Consortium (ARC) definition
Time frame: 1-year and 2-year follow-up post procedure
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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