Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial
VULNERABLE
1 other identifier
interventional
600
1 country
49
Brief 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 ST-elevation myocardial infarction (STEMI) and multivessel disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Jan 2023
Longer than P75 for not_applicable coronary-artery-disease
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 29, 2026
January 1, 2026
5.8 years
October 25, 2022
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Vessel Failure (TVF)
TVF as a composite of : Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
4 Years
Secondary Outcomes (11)
Cardiac death
4 Years
All-cause Death
4 Years
All Myocardial Infarctions
4 Years
Target-Vessel Myocardial Infarction
4 Years
Revascularizations
4 Years
- +6 more secondary outcomes
Study Arms (2)
Optimal Medical Treatment (OMT) + PCI
EXPERIMENTALOptimal Medical Treatment (OMT)
ACTIVE COMPARATORInterventions
Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
Eligibility Criteria
You may qualify if:
- 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 ).
- Informed consent signed.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
- Abbottcollaborator
Study Sites (49)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario de Albacete
Albacete, 02006, Spain
Hospital General Universitario Dr.Balmis
Alicante, 03010, Spain
Hospital Universitari Sant Joan D'Alacant
Alicante, 03550, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital de Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Puerta Del Mar
Cadiz, 11009, Spain
Hospital General Universitario de Castellón
Castellon, 12004, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Universitario Reina Sofia de Cordoba
Córdoba, 14004, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital Universitario de Cabueñes
Gijón, 33394, Spain
Hospital Universitario de Girona Dr Trueta
Girona, 17007, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Chu de Toledo
Guadalajara, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
H.U. de Gran Canaria-Dr. Negrin
Las Palmas de Gran Canaria, 35010, Spain
H.I.U. Materno Infantil de Las Palmas
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario de Leon
León, 24001, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Hospital de Manises
Manises, 46940, Spain
Hospital de Merida
Mérida, 06800, Spain
Hospital Universitario Virgen Arrixaca
Murcia, 30120, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Donostia
San Sebastián, 20014, Spain
Hospital Universitario Nuestra Señora de La Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari Joan Xxiii
Tarragona, 43005, Spain
Hospital Universitari MútuaTerrassa
Terrassa, 08221, Spain
Hospital Universitario de Torrevieja
Torrevieja, 03186, Spain
Hospital Universitario 12 Octubre
Usera, 28041, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitari Miquel Servet
Zaragoza, 50009, Spain
Related Publications (6)
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.
PMID: 33999545BACKGROUNDMehta 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.
PMID: 31475795BACKGROUNDErlinge 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.
PMID: 33714389BACKGROUNDStone 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.
PMID: 33069847BACKGROUNDDenormandie 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.
PMID: 34420366BACKGROUNDGomez-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/RECIC.M24000468. eCollection 2024 Oct-Dec.
PMID: 40444169DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 31, 2022
Study Start
January 30, 2023
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
January 29, 2026
Record last verified: 2026-01