Coronary Artery Disease
Conditions
Keywords
Drug Eluting Stents, Strut coverage by optic coherence tomography, Early endothelization
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.
Interventions
DEVICEVIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
DEVICEXIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Percentage of covered struts at 1 months OCT after stent implantation | 1 month | Percentage of covered struts at 1 months 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 |
| Myocardial Infarction Rate at 6 months | 6 months | Myocardial Infarction Rate at 6 months |
| Target vessel revascularization Rate at 6 months | 6 months | Target vessel revascularization Rate at 6 months |
| 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. |
Countries
Spain
Outcome results
None listed