Clinical trial NCT06214819: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug Eluting Stents
Strut coverage by optic coherence tomography
Early endothelization
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
timeFrame: 1 month
measure: Percentage of stents with uncovered struts at 1 month OCT after stent implantation
timeFrame: 1 month
measure: Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of malapposition of stent at 1 month OCT after stent implantation
timeFrame: 1 month
measure: Percentage of covered struts at 1 months OCT after stent implantation
timeFrame: 1 month
measure: All-Cause Death Rate at 6 months
timeFrame: 6 months
measure: Cardiac Death Rate at 6 months
timeFrame: 6 months
measure: Myocardial Infarction Rate at 6 months
timeFrame: 6 months
measure: Target vessel revascularization Rate at 6 months
timeFrame: 6 months
measure: Neointimal Healing Score (NHC) by OCT at 1 month
timeFrame: 1 months
measure: Percentage of malapposed total struts at 1 month
timeFrame: 1 month
measure: Percentage of malapposed scaffold struts over side branch at 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Girona
country: Spain
facility: Hospital Universitario de Gerona Doctor Josep Trueta
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.