Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

NARecruitingINTERVENTIONAL
Enrollment

1,420

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Coronary Artery DiseaseCoronary DiseaseIschemic Heart Disease
Interventions
DEVICE

Optical coherence tomography

OCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.

DEVICE

iFR/FFR/RFR

The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).

Trial Locations (34)

3010

RECRUITING

Inselspital, Bern University Hospital, Bern

10098

RECRUITING

Rivoli Hospital, Rivoli

16132

RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

20138

RECRUITING

Centro Cardiologico Monzino IRCCS, Milan

20157

RECRUITING

IRCCS Galeazzi- Sant'Ambrogio, Milan

24127

RECRUITING

ASST Papa Giovanni XXIII, Bergamo

26504

RECRUITING

University Hospital of Patras, Pátrai

28006

RECRUITING

Hospital universitario La Princesa, Madrid, Madrid

29010

RECRUITING

Hospital Virgen de la Victoria, Málaga

31015

RECRUITING

Ospedale Conegliano, Conegliano

33011

RECRUITING

Hospital Universitario Central de Asturias, Oviedo

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital, Udine

40138

RECRUITING

Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola, Bologna

53100

RECRUITING

UOSA Cardiologia Interventistica, Siena

58100

RECRUITING

Misericordia Hospital, Grosseto

63100

RECRUITING

Ospedale C. e G. Mazzoni, Ascoli Piceno

70021

RECRUITING

"Ente ecclesiastico Ospedale Regionale Generale F. Miulli", Acquaviva delle Fonti

70120

RECRUITING

Policlinico University Hospital, Bari

70131

RECRUITING

Di Venere Hospital, Bari

71013

RECRUITING

IRCCS Casa sollievo della sofferenza, San Giovanni Rotondo

73100

RECRUITING

Ospedale Vito Fazzi, Lecce

80138

RECRUITING

Federico II di Napoli, Napoli

81031

RECRUITING

P.O. San Giuseppe Moscati, Aversa

82100

RECRUITING

Azienda Ospedaliera San Pio, Benevento

95123

NOT_YET_RECRUITING

"Azienda Ospedaliera Policlinico G. Rodolico- San Marco", Catania

95126

RECRUITING

Azienda Ospedaliera Per L'emergenza Cannizzaro, Catania

96100

RECRUITING

P.O. Umberto I, Syracuse

98124

RECRUITING

"Azienda Ospedaliero Universitaria Policlinico G. Martino, Messina", Messina

09047

RECRUITING

ARNAS Brotzu, Cagliari

04100

RECRUITING

Ospedale Santa Maria Goretti, Latina, Latina

00152

RECRUITING

San Camillo Hospital, Roma

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

07100

NOT_YET_RECRUITING

Struttura Complessa di Cardiologia Clinica e Interventistica, Sassari

00184

RECRUITING

San Giovanni Hospital, Rome

All Listed Sponsors
collaborator

Abbott Vascular (Santa Clara, USA)

UNKNOWN

lead

Centro per la Lotta Contro l'Infarto - Fondazione Onlus

OTHER