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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.

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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)

Study details

Coronary Artery Disease

NCT06214819

Fundación EPIC

23 June 2024

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