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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2030-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Comparator: ihtDEStiny® DES

Group Type OTHER

ihtDEStiny® DES implanted

Intervention Type DEVICE

ihtDEStiny® DES implanted

Experimental: Xience™ DES

Group Type OTHER

Xience™ DES implanted

Intervention Type DEVICE

Xience™ DES implanted

Interventions

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ihtDEStiny® DES implanted

Intervention Type DEVICE

Xience™ DES implanted

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No