Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice (VELAZQUEZ)

Fundación EPIC

Status: Active, not recruiting

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Device: Percutaneous Coronary Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04899141

EPIC26-VELAZQUEZ

Details and patient eligibility

About

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

Full description

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

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Coronary Artery Disease

Treatment:

Device: Percutaneous Coronary Intervention