Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

N/AActive Not RecruitingNCT04899141

Fundación EPIC400 enrolled

Overview

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.

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

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Coronary Artery Disease Ischemic Heart Disease

Interventions

Percutaneous Coronary InterventionDEVICE

stenting with the ihtDEStiny® sirolimus eluting stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Centro Hospitalar Universitario Do Algarbe

Faro, Portugal

Hospital Universitario Regional de Malaga Carlos Haya

Outcomes

Primary Outcomes

Target Lesion Failure (TLF)

Rate of target lesion failure

Time frame: 2 years

Target Lesion Failure (TLF)

Rate of target lesion failure

Time frame: 5 years

Death

Time frame: 2 years

Death

Time frame: 5 years

Target vessel myocardial infarction

Time frame: 2 years

Target vessel myocardial infarction

Time frame: 5 years

Target lesion revascularization (TLR)

Time frame: 2 years

Target lesion revascularization (TLR)

Time frame: 5 years

Cardiovascular Death

Time frame: 2 years

Cardiovascular Death

Time frame: 5 years

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Stent thrombosis

Time frame: 2 years

Stent thrombosis

Time frame: 5 years

Target Vessel Failure (TVF)

Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)

Time frame: 2 years

Target Vessel Failure (TVF)

Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)

Time frame: 5 years

Major Adverse Cardiovascular Event (MACE)

Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

Time frame: 2 years

Major Adverse Cardiovascular Event (MACE)

Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

Time frame: 5 years

Patient Oriented Composite Event

Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization

Time frame: 2 years

Patient Oriented Composite Event

Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization

Time frame: 5 years

Severe BARC Bleeding

BARC Bleeding ≥3

Time frame: 2 years

Severe BARC Bleeding

BARC Bleeding ≥3

Time frame: 5 years

Device success

residual coronary stenosis\<50%, normal coronary flow and absence of coronary dissection ≥C

Time frame: During procedure

Procedural success

Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days

Time frame: 3 days