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.

NCT06214819 | Active Not Recruiting DMC

• 1 other identifier: EPIC31-PRO-HEAL TRIAL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stents; Strut coverage by optic coherence tomography; Early endothelization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

  1 month

• All-Cause Death Rate at 6 months

  6 months

• Cardiac Death Rate at 6 months

  6 months

• Myocardial Infarction Rate at 6 months

  6 months

Study Arms (2)

VIVO ISAR DES in the first lesion

EXPERIMENTAL

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

XIENCE Skypoint DES in the first lesion

ACTIVE COMPARATOR

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

Interventions

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

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

VIVO ISAR DES in the first lesion

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

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

XIENCE Skypoint DES in the first lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (4)

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Gerona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Related Publications (5)

• 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.

  PMID: 29544956 BACKGROUND

• 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.

  PMID: 30082261 BACKGROUND

• 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.

  PMID: 36740229 BACKGROUND

• 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.

  PMID: 35472561 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 22, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

ES (4)