Status:
ACTIVE_NOT_RECRUITING
Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
October 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04899141
Start Date
October 29 2021
End Date
April 1 2025
Last Update
January 14 2025
Active Locations (20)
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1
Centro Hospitalar Universitario Do Algarbe
Faro, Portugal, 8000-386
2
Hospital Universitario Regional de Malaga Carlos Haya
Málaga, Malaga, Spain, 29010
3
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
4
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035