Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Drug Eluting Stent
Brief summary
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.
Detailed description
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention
Interventions
DEVICEPercutaneous Coronary Intervention
stenting with the ihtDEStiny® sirolimus eluting stent
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines * 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted). * Informed consent signed after PCI
Exclusion criteria
* Patient refusal to participate in the study * Pregnancy * Other DES implantation during index PCI, or 30 days before of after index PCI * PCI at surgical grafts * PCI for in-stent restenosis * Killip class 3-4 Acute Coronary Syndromes (ACS) * High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI) * Allergy or hypersensitivity to sirolimus * Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI * Patients with life expectancy \<2 years * Patients included in other trials or clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 2 years | Rate of target lesion failure |
| Death | 2 years | Death |
| Target vessel myocardial infarction | 2 years | Target vessel myocardial infarction |
| Target lesion revascularization (TLR) | 2 years | Target lesion revascularization (TLR) |
| Cardiovascular Death | 2 years | Cardiovascular Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | 2 years | Stent thrombosis |
| Target Vessel Failure (TVF) | 2 years | Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR) |
| Major Adverse Cardiovascular Event (MACE) | 2 years | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke |
| Patient Oriented Composite Event | 2 years | Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization |
| Severe BARC Bleeding | 2 years | BARC Bleeding ≥3 |
| Device success | During procedure | residual coronary stenosis\<50%, normal coronary flow and absence of coronary dissection ≥C |
| Procedural success | 3 days | Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days |
Countries
Portugal, Spain
Outcome results
None listed