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.

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion; Device: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion

• Registration Number: NCT06214819
• Lead Sponsor: Fundación EPIC

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-22
• Study Start: 2024-03-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIVO ISAR DES in the first lesion	VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion	-
XIENCE Skypoint DES in the first lesion	XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion	-

Primary Outcome Measures

Name	Time	Method
Percentage of stents with uncovered struts at 1 month OCT after stent implantation	1 month	Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation	1 month	Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation	1 month	Mean thickness of struts tissue coverage at 1 month OCT after stent implantation

Secondary Outcome Measures

Name	Time	Method
Neointimal Healing Score (NHC) by OCT at 1 month	1 months	The NHS is then calculated as follows: 1. Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4"; 2. Presence of both malapposed and uncovered struts (% malapposed/uncovered, MU) is assigned a weight of "3"; 3. Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"; 4. Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1" Neointimal healing score = (%ILD \* 4)+(%MU \* 3)+(%U \* 2)+(%M \* 1).
Percentage of malapposed total struts at 1 month	1 month	Percentage of malapposed total struts at 1 month
Percentage of malapposed scaffold struts over side branch at 1 month	1 month	Strut malapposition: Measured maximum distance ≥100 μm between the strut surface and adjacent vessel surface by OCT, considering thickness of scaffold, was defined as malapposition. As a result, scaffold malapposition is defined as the presence of any malapposed struts. The ratio of malapposed struts (% malapposed strut) was the ratio of malapposed struts from total analyzable struts.
Percentage of malapposition of stent at 1 month OCT after stent implantation	1 month	Percentage of malapposition of stent at 1 month OCT after stent implantation
All-Cause Death Rate at 6 months	6 months	All-Cause Death Rate at 6 months
Cardiac Death Rate at 6 months	6 months	Cardiac Death Rate at 6 months
Target vessel revascularization Rate at 6 months	6 months	Target vessel revascularization Rate at 6 months
Percentage of covered struts at 1 months OCT after stent implantation	1 month	Percentage of covered struts at 1 months OCT after stent implantation
Myocardial Infarction Rate at 6 months	6 months	Myocardial Infarction Rate at 6 months

Trial Locations

Locations (4)

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de Gerona Doctor Josep Trueta; 🇪🇸 Girona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Spain