Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Study Overview
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Brief Summary
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Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.

Detailed Description
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Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention

Official Title
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Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease<br> | Device: Percutaneous Coronary Intervention<br>* stenting with the ihtDEStiny® sirolimus eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Rate of target lesion failure | 2 years | 
| Death | Death | 2 years | 
| Target vessel myocardial infarction | Target vessel myocardial infarction | 2 years | 
| Target lesion revascularization (TLR) | Target lesion revascularization (TLR) | 2 years | 
| Cardiovascular Death | Cardiovascular Death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis | Stent thrombosis | 2 years | 
| Target Vessel Failure (TVF) | Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR) | 2 years | 
| Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 2 years | 
| Patient Oriented Composite Event | Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization | 2 years | 
| Severe BARC Bleeding | BARC Bleeding ≥3 | 2 years | 
| Device success | residual coronary stenosis<50%, normal coronary flow and absence of coronary dissection ≥C | During procedure | 
| Procedural success | Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Drug Eluting Stent