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Coronary Artery DiseaseVULNERABLENCT05599061

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

A study testing FFR>0.80+ OCT with findings indicative of vulnerable plaque in people with Coronary Artery Disease and Coronary Disease, run by Fundación EPIC at 49 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

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Could I receive a placebo?
No, everyone receives an active treatment
How many people
609 participants
Where
49 sitesSpain
Study dates
30 Jan 2023to 1 Dec 2028
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 > 18 years.
  • Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (> 1mm in > 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads) in the first 72 hours of the symptom's onset.
  • Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (>24 hours and <60 days after PCI of the culprit lesion).
  • Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ).
  • Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study.
  • Informed consent signed.

Who cannot join

  • Inability to provide informed consent.
  • Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Known intolerance to aspirin, heparin, everolimus, contrast material.
  • Unresolved mechanical complication or cardiogenic shock at the staged procedure.
  • Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion.
  • Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation.
Show all 10Show fewer
  • Asthma or known history of bronchial hyper-reactivity.
  • Chronic renal dysfunction with creatinine clearance < 45 ml/min.
  • Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy < 4 years.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

Spain49 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital General Universitario de Albacete

    Albacete, 02006

  • Hospital General Universitario Dr.Balmis

    Alicante, 03010

  • Hospital Universitari Sant Joan D'Alacant

    Alicante, 03550

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital de Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009

  • Hospital General Universitario de Castellón

    Castellon, 12004

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Reina Sofia de Cordoba

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, 03203

  • Hospital Universitario de Cabueñes

    Gijón, 33394

  • Hospital Universitario de Girona Dr Trueta

    Girona, 17007

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Chu de Toledo

    Guadalajara

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • H.U. de Gran Canaria-Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • H.I.U. Materno Infantil de Las Palmas

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario de Leon

    León, 24001

  • Hospital La Princesa

    Madrid, 28006

  • Hospital Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222

  • Hospital de Manises

    Manises, 46940

  • Hospital de Merida

    Mérida, 06800

  • Hospital Universitario Virgen Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Donostia

    San Sebastián, 20014

  • Hospital Universitario Nuestra Señora de La Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitari Joan Xxiii

    Tarragona, 43005

  • Hospital Universitari MútuaTerrassa

    Terrassa, 08221

  • Hospital Universitario de Torrevieja

    Torrevieja, 03186

  • Hospital Universitario 12 Octubre

    Usera, 28041

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitari Miquel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Read the detailed description

STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR > 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.

Being tested
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Keywords
Vulnerable Plaque, Optical Coherence Tomography, Fractional Flow Reserve and ST-elevation Myocardial Infarction
Medical subject headings
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, ST Elevation Myocardial Infarction

What participants receive

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

  • FFR>0.80+ OCT with findings indicative of vulnerable plaqueOther

    Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

  • FFR>0.80+ OCT with findings indicative of vulnerable plaqueOther

    OPTIMAL MEDICAL TREATMENT (OMT)

Study groups in NCT05599061
Study groupRoleWhat they receive
Optimal Medical Treatment (OMT) + PCIExperimentalNot described
Receives: Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Optimal Medical Treatment (OMT)Active comparatorNot described
Receives: Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque

What is being measured

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

  1. Target Vessel Failure (TVF)

    TVF as a composite of :

    Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization

    Measured: 4 Years

Secondary outcomes (11)

  1. Cardiac death

    To compare Cardiac death between both groups in the randomized arm death.

    Measured: 4 Years

  2. All-cause Death

    To compare all death between both groups in the randomized arm death.

    Measured: 4 Years

  3. All Myocardial Infarctions

    To compare Myocardial Infarctions between both groups in the randomized arm death. death

    Measured: 4 Years

  4. Target-Vessel Myocardial Infarction

    To compare target-vessel myocardial infarction between both groups in the randomized arm.

    Measured: 4 Years

  5. Revascularizations

    To compare all revascularizations between both groups in the randomized arm.

    Measured: 4 Years

  6. Ischemic-driven target vessel revascularization

    To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.

    Measured: 4 Years

  7. Patient-oriented endpoint of major adverse cardiac events

    To compare the patient-oriented endpoint of major adverse cardiac events, a composite of all-cause death, myocardial infarction, and revascularization between both groups in the randomized arm.

    Measured: 4 Years

  8. Target Vessel Failure (TVF)

    To compare the TVF rate between patients included in the OMT group of the randomized arm (presenting with vulnerable plaque) vs. patients included in the OMT registry (without vulnerable plaque).

    Measured: 4 Years

  9. Fractional Flow Reserve (FFR)

    To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).

    Measured: 4 years

  10. Minimal lumen area by Optical Coherence Tomography (OCT)

    To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.

    Measured: 4 years

  11. Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT)

    To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.

    Measured: 4 years

Timeline

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

  1. First posted31 Oct 2022
  2. Study start30 Jan 2023
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599061
Sponsor's protocol ID
EPIC28-VULNERABLE
Acronym
VULNERABLE
Status last verified
Jul 2026
First submitted
25 Oct 2022
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

    PubMed 33999545

  • Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.

    PubMed 31475795

  • Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

    PubMed 33714389

  • Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.

    PubMed 33069847

  • Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.

    PubMed 34420366

  • Gomez-Lara J, Lopez-Palop R, Rumiz E, Jurado-Roman A, Gomez-Menchero A, Valencia J, Fernandez E, Goncalves Ramirez LR, Brugaletta S, Millan R, Cortes C, Tejedor P, Gutierrez-Barrios A, Flores X, Cid-Alvarez AB, Garcia-Blas S, Garcia-Camarero T, Linares Vicente JA, Vaquerizo B, Cordoba Soriano JG, Caballero J, Cardenal Piris RM, Sanchez-Elvira G, Oyarzabal L, Pernigotti A, Tramullas A, Antuna P, Rodriguez-Leor O, Ojeda S, Rossello X, Gomez-Hospital JA, Bermejo J, Garcia-Garcia HM, Perez de Prado A, Gutierrez-Ibanes E. Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial. REC Interv Cardiol. 2024 Jul 4;6(4):278-286. doi: 10.24875/RECICE.M24000468. eCollection 2024 Oct-Dec.

    PubMed 40444169

Questions about this trial

What is this clinical trial studying?

A study testing FFR>0.80+ OCT with findings indicative of vulnerable plaque in people with Coronary Artery Disease and Coronary Disease, run by Fundación EPIC at 49 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 6 inclusion and 10 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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?

Target Vessel Failure (TVF) (time frame: 4 Years). 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 NCT05599061, which also lists 6 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 15 Jul 2026.

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