Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.

Fundación EPIC

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion; Device: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion

Study type: Interventional

Funder types: Other

Identifiers

NCT06214819

EPIC31-PRO-HEAL TRIAL

Details and patient eligibility

About

To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.

Full description

To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with age ≥ 18 years AND
• Patients who have signed informed consent AND
• Patients with coronary artery disease requiring percutaneous treatment with coronary stents due to de novo lesions in vessels with a diameter of reference from 2.25 mm to 4.0 mm AND
• Patients with at least 2 angiographic lesions in 2 different major coronary arteries. Or in the main branch and in one of its subsidiaries branches , as long as those are not "downstream" of the lesion from the main branch

Exclusion criteria

• Express refusal of the patient to participate in the study

• Patients with ST elevation Myocardial Infarction or Cardiogenic Shock

• Patients with high thrombotic content

• Pregnant or breastfeeding patients

• Patients with complex PCI (Percutaneous Coronary Intervention )(defined as):

  • Left main PC
  • Chronic total PC occlusion
  • Bifurcation lesion requiring 2-stent technique .

• Severe calcified lesion (need to use prior complex techniques of calcium modification such as intravascular lithotripsy, rotational/orbital atherectomy, laser.

• Patients with malignant neoplasms or other comorbid conditions with life expectancy <12 months

• Patients with a target lesion in a bypass graft

• Lesions due to restenosis

• Patients with PCI in the target vessel in the previous 9 months

• Patients with contraindication or difficulty to evaluate in the follow-up with OCT (renal failure, excessive tortuosity or lesions aorto-ostial)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VIVO ISAR DES in the first lesion

Experimental group

Treatment:

Device: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion

XIENCE Skypoint DES in the first lesion

Active Comparator group

Treatment:

Device: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion