Health TrialsbyHealthPanel

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

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ihtDEStiny® DES implanted

    Device

    ihtDEStiny® DES implanted

  • Xience™ DES implanted

    Device

    Xience™ DES implanted

Treatment groups

2,100 Participants
are divided into 2 treatment groups
Group A: Active Comparator: ihtDEStiny® DESOther 1 intervention
Group B: Experimental: Xience™ DESOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months
2

NACE

Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events

Time frame
12 months

Secondary outcomes

1

All-Cause Death Rate at 12 months

All-Cause Death Rate at 12 months

Time frame
12 months
2

All-Cause Death Rate at 24 months

All-Cause Death Rate at 24 months

Time frame
12 months
3

Cardiac Death Rate at 12 months

Cardiac Death Rate at 12 months

Time frame
12 months
4

Cardiac Death Rate at 24 months

Cardiac Death Rate at 24 months

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
Apply now