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.

Last updated: December 19, 2024
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiovascular Disease

Chest Pain

Treatment

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

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

Clinical Study ID

NCT06214819
EPIC31-PRO-HEAL TRIAL
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with age ≥ 18 years AND

  • Patients who have signed informed consent AND

  • Patients with coronary artery disease requiring percutaneous treatment with coronarystents due to de novo lesions in vessels with a diameter of reference from 2.25 mmto 4.0 mm AND

  • Patients with at least 2 angiographic lesions in 2 different major coronaryarteries. Or in the main branch and in one of its subsidiaries branches , as long asthose are not "downstream" of the lesion from the main branch

Exclusion

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 calciummodification 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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Gerona Doctor Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.