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

NCT05599061 | Active Not Recruiting DMC

• 1 other identifier: EPIC28-VULNERABLE
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 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.

Conditions

Coronary Artery Disease; Coronary Disease; Ischemic Heart Disease

Keywords

Vulnerable Plaque; Optical Coherence Tomography; Fractional Flow Reserve and ST-elevation Myocardial Infarction

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

Study Arms (2)

Optimal Medical Treatment (OMT) + PCI

EXPERIMENTAL

Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque

Optimal Medical Treatment (OMT)

ACTIVE COMPARATOR

Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque

Interventions

FFR>0.80+ OCT with findings indicative of vulnerable plaque OTHER

Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

Optimal Medical Treatment (OMT) + PCI

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Fundación EPIC: lead
• Abbott: collaborator

Study Sites (49)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital General Universitario Dr.Balmis

Alicante, 03010, Spain

Location

Hospital Universitari Sant Joan D'Alacant

Alicante, 03550, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital de Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital General Universitario de Castellón

Castellon, 12004, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia de Cordoba

Córdoba, 14004, Spain

Location

Hospital General Universitario de Elche

Elche, 03203, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario de Girona Dr Trueta

Girona, 17007, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Chu de Toledo

Guadalajara, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

H.U. de Gran Canaria-Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

H.I.U. Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario de Leon

León, 24001, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Hospital de Merida

Mérida, 06800, Spain

Location

Hospital Universitario Virgen Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario de Donostia

San Sebastián, 20014, Spain

Location

Hospital Universitario Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitari Joan Xxiii

Tarragona, 43005, Spain

Location

Hospital Universitari MútuaTerrassa

Terrassa, 08221, Spain

Location

Hospital Universitario de Torrevieja

Torrevieja, 03186, Spain

Location

Hospital Universitario 12 Octubre

Usera, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitari Miquel Servet

Zaragoza, 50009, Spain

Location

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: 33999545 BACKGROUND

• 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.

  PMID: 31475795 BACKGROUND

• 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.

  PMID: 33714389 BACKGROUND

• 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.

  PMID: 33069847 BACKGROUND

• 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.

  PMID: 34420366 BACKGROUND

• 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.

  PMID: 40444169 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

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: July 15, 2026

Record last verified: 2026-07

Locations

ES (49)