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Coronary Artery DiseaseNCT06214819

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.

A study testing VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion and XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion in people with Coronary Artery Disease, run by Fundación EPIC at 4 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion and XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesSpain
Study dates
20 Mar 2024to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario de Gerona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
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
Keywords
Drug Eluting Stents, Strut coverage by optic coherence tomography, Early endothelization
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 lesionDevice

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

Study groups in NCT06214819
Study groupRoleWhat they receive
VIVO ISAR DES in the first lesionExperimentalNot described
Receives: Device: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
XIENCE Skypoint DES in the first lesionActive comparatorNot described
Receives: Device: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

  2. 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

    Measured: 1 month

  3. 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

    Measured: 1 month

Secondary outcomes (9)

  1. Percentage of malapposition of stent at 1 month OCT after stent implantation

    Percentage of malapposition of stent at 1 month OCT after stent implantation

    Measured: 1 month

  2. Percentage of covered struts at 1 months OCT after stent implantation

    Percentage of covered struts at 1 months OCT after stent implantation

    Measured: 1 month

  3. All-Cause Death Rate at 6 months

    All-Cause Death Rate at 6 months

    Measured: 6 months

  4. Cardiac Death Rate at 6 months

    Cardiac Death Rate at 6 months

    Measured: 6 months

  5. Myocardial Infarction Rate at 6 months

    Myocardial Infarction Rate at 6 months

    Measured: 6 months

  6. Target vessel revascularization Rate at 6 months

    Target vessel revascularization Rate at 6 months

    Measured: 6 months

  7. 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).

    Measured: 1 months

  8. Percentage of malapposed total struts at 1 month

    Percentage of malapposed total struts at 1 month

    Measured: 1 month

  9. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start20 Mar 2024
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214819
Sponsor's protocol ID
EPIC31-PRO-HEAL TRIAL
Status last verified
Apr 2026
First submitted
13 Dec 2023
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29544956

  • 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.

    PubMed 30082261

  • 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.

    PubMed 36740229

  • 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.

    PubMed 35472561

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion and XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion in people with Coronary Artery Disease, run by Fundación EPIC at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214819, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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