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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
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
L'Hospitalet de Llobregat, Spain
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of stents with uncovered struts at 1 month OCT after stent implantation
Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation
Time frame: 1 month
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of malapposition of stent at 1 month OCT after stent implantation
Percentage of malapposition of stent at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of covered struts at 1 months OCT after stent implantation
Percentage of covered struts at 1 months OCT after stent implantation
Time frame: 1 month
All-Cause Death Rate at 6 months
All-Cause Death Rate at 6 months
Time frame: 6 months
Cardiac Death Rate at 6 months
Cardiac Death Rate at 6 months
Time frame: 6 months
Myocardial Infarction Rate at 6 months
Myocardial Infarction Rate at 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Target vessel revascularization Rate at 6 months
Target vessel revascularization Rate at 6 months
Time frame: 6 months
Neointimal Healing Score (NHC) by OCT at 1 month
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).
Time frame: 1 months
Percentage of malapposed total struts at 1 month
Percentage of malapposed total struts at 1 month
Time frame: 1 month
Percentage of malapposed scaffold struts over side branch at 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.
Time frame: 1 month