Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Active, not recruiting

• Conditions: Ischemic Heart Disease; Coronary Artery Disease
• Interventions: Device: Percutaneous Coronary Intervention

• Registration Number: NCT04899141
• Lead Sponsor: Fundación EPIC

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

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-10-29
• Primary Completion: 2023-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease	Percutaneous Coronary Intervention	-

Primary Outcome Measures

Name	Time	Method
Death	2 years	Death
Target Lesion Failure (TLF)	2 years	Rate of target lesion failure
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 Outcome Measures

Name	Time	Method
Stent thrombosis	2 years	Stent thrombosis
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
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
Target Vessel Failure (TVF)	2 years	Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)
Severe BARC Bleeding	2 years	BARC Bleeding ≥3

Trial Locations

Locations (20)

Centro Hospitalar Universitario Do Algarbe; 🇵🇹 Faro, Portugal

Hospital Universitario Regional de Malaga Carlos Haya; 🇪🇸 Málaga, Malaga, Spain

Hospital Universitario de Cruces; 🇪🇸 Barakaldo, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital San Pedro de Alcantara; 🇪🇸 Cáceres, Spain

Hospital Universitario Donostia; 🇪🇸 Donostia, Spain

Hospital Universitario de Araba; 🇪🇸 Gasteiz / Vitoria, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Spain

Hospital de Galdakao; 🇪🇸 Galdakao, Spain

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain

Hospital Universitari Arnau de Vilanova de Lleida; 🇪🇸 Lleida, Spain

Hospital Universitario Virgen Arrixaca; 🇪🇸 Murcia, Spain

Hospital Universitario Virgen de La Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital Clinico Universitario Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain