Comparison of a Contemporary Sirolimus-eluting Stent (iht... | NCT07190690

Studies
Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions

NCT07190690

Sponsor

Fundación EPIC

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

2,100Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

ihtDEStiny® DES implanted
Xience™ DES implanted

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2025Actual

Primary Completion Date

Oct 15, 2029Estimated

Completion Date

Oct 15, 2030Estimated

First Submitted Date

Sep 17, 2025

First Submission Date that Met QC Criteria

Sep 17, 2025

First Posted Date

Sep 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).

To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.

Detailed Description

To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).

To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,100Estimated

Label	Type	Description	Intervention Names
Active Comparator: ihtDEStiny® DES	Other		Device: ihtDEStiny® DES implanted
Experimental: Xience™ DES	Other		Device: Xience™ DES implanted

Name	Type	Description	Arm Group Labels	Other Names
ihtDEStiny® DES implanted	Device	ihtDEStiny® DES implanted	Active Comparator: ihtDEStiny® DES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EFFICACY: Device-oriented Composite Endpoint (DoCE)	Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)	12 months
NACE	Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events	12 months

Secondary Outcomes

Measure	Description	Time Frame
All-Cause Death Rate at 12 months	All-Cause Death Rate at 12 months	12 months
All-Cause Death Rate at 24 months	All-Cause Death Rate at 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who meet ALL inclusion criteria will be included:

Patients aged ≥18 years, and
Patients diagnosed with an acute coronary syndrome (ACS), either SCASEST (Acute Coronary Syndrome without Persistent ST-Segment Elevation) or IAMCEST (Acute Myocardial Infarction with Persistent ST-Segment Elevation), for which they will undergo PCI, and
Patients with de novo lesions in vessels with a reference diameter of ≥2.25 mm and ≤4.5 mm in whom implantation of one or more DES is clinically indicated, and
Patients who have been informed of the characteristics of the study and have provided written informed consent.

Exclusion Criteria:

Patients must not meet any of the following exclusion criteria:

Patients in cardiogenic shock according to the severity criteria defined by the Society of Cardiovascular Angiography and Interventions (SCAI): "C" (Classic Shock), "D" (Deteriorating) and "E" (Extremis).
Patients unable to provide informed consent.
Patients with a known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agents, or any of the components of DES.
Patients with active bleeding at the time of PCI requiring medical attention.
Patients with planned surgery within the next 3 months.
Patients with any medical condition that limits a life expectancy of less than 12 months.
Patients participating in another clinical trial in which the primary endpoint was not met.
Pregnant or breastfeeding women of childbearing potential with a positive pregnancy test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Armando Pérez de Prado, MD, PhD	Contact	0034987876135		admin@fundacionepic.org
FUNDACION EPIC	Contact	0034987876135		iepic@fundacionepic.org

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario San Juan Alicante	Recruiting	Alicante		03550	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33386256	Background	de la Torre Hernandez JM, Otaegui I, Subinas A, Gomez-Menchero A, Moreno R, Rondan J, Munoz-Garcia E, Sainz-Laso F, Garcia Del Blanco B, Rumoroso JR, Diaz JF, Berenguer A, Gomez-Lara J, Zueco J. First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study. Cardiovasc Revasc Med. 2021 Nov;32:18-24. doi: 10.1016/j.carrev.2020.12.025. Epub 2020 Dec 29.
34391680

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases