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.

Randomized, Controlled, Open-label, Double-blind, Multicenter Investigation 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.

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: BRUNO GARCIA DEL BLANCO, MD, PhD; Phone Number: 0034932746155; Email: brunogb51@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIVO ISAR DES in the first lesion	Device: VIVO 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
Active Comparator: XIENCE Skypoint DES in the first lesion	Device: XIENCE 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of malapposition of stent at 1 month OCT after stent implantation	Percentage of malapposition of stent at 1 month OCT after stent implantation	1 month
Percentage of covered struts at 1 months OCT after stent implantation	Percentage of covered struts at 1 months OCT after stent implantation	1 month
All-Cause Death Rate at 6 months	All-Cause Death Rate at 6 months	6 months
Cardiac Death Rate at 6 months	Cardiac Death Rate at 6 months	6 months
Myocardial Infarction Rate at 6 months	Myocardial Infarction Rate at 6 months	6 months
Target vessel revascularization Rate at 6 months	Target vessel revascularization Rate at 6 months	6 months
Neointimal Healing Score (NHC) by OCT at 1 month	The NHS is then calculated as follows: Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4"; Presence of both malapposed and uncovered struts (% malapposed/uncovered, MU) is assigned a weight of "3"; Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"; Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1" Neointimal healing score = (%ILD * 4)+(%MU * 3)+(%U * 2)+(%M * 1).	1 months
Percentage of malapposed total struts at 1 month	Percentage of malapposed total struts at 1 month	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.	1 month

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Koppara T, Tada T, Xhepa E, Kufner S, Byrne RA, Ibrahim T, Laugwitz KL, Kastrati A, Joner M. Randomised comparison of vascular response to biodegradable polymer sirolimus eluting and permanent polymer everolimus eluting stents: An optical coherence tomography study. Int J Cardiol. 2018 May 1;258:42-49. doi: 10.1016/j.ijcard.2018.01.011.
• Asano T, Jin Q, Katagiri Y, Kogame N, Takahashi K, Chang CC, Chichareon P, Wang C, Shi B, Su X, Fu G, Wu Y, Zhou X, Yuan Z, Wykrzykowska JJ, Piek JJ, Serruys PW, Onuma Y, Chen Y. A randomised comparison of healing response between the BuMA Supreme stent and the XIENCE stent at one-month and two-month follow-up: PIONEER-II OCT randomised controlled trial. EuroIntervention. 2018 Dec 20;14(12):e1306-e1315. doi: 10.4244/EIJ-D-18-00461.
• Andreasen LN, Balleby IR, Barkholt TO, Hebsgaard L, Terkelsen CJ, Holck EN, Jensen LO, Maeng M, Dijkstra J, Antonsen L, Kristensen SD, Tu S, Lassen JF, Christiansen EH, Holm NR. Early healing after treatment of coronary lesions by thin strut everolimus, or thicker strut biolimus eluting bioabsorbable polymer stents: The SORT-OUT VIII OCT study. Catheter Cardiovasc Interv. 2023 Mar;101(4):787-797. doi: 10.1002/ccd.30579. Epub 2023 Feb 5.
• Otaegui Irurueta I, Gonzalez Sucarrats S, Barron Molina JL, Perez de Prado A, Massotti M, Carmona Ramirez MA, Marti G, Bellera N, Serra B, Serra V, Domingo E, Lopez-Benito M, Sabate M, Ferreira Gonzalez I, Garcia Del Blanco B. Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent. Int J Cardiol. 2022 Aug 1;360:13-20. doi: 10.1016/j.ijcard.2022.04.043. Epub 2022 Apr 25.
• Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, et al. Polymerfree sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISARTEST 5) trial. Circulation. 2 de agosto de 2011;124(5):624-32. 18. Kufner S, Sorges J, Mehilli J, Cassese S, Repp J, Wiebe J, et al. Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents: 5-Year Results of the ISAR-TEST-5 Trial. JACC Cardiovasc Interv. 25 de abril de 2016;9(8):784-92.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Drug Eluting Stents; Strut coverage by optic coherence tomography; Early endothelization
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EPIC31-PRO-HEAL TRIAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No