Clinical Research Directory
Browse clinical research sites, groups, and studies.
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Sponsor: Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Summary
The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.
Official title: An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1420
Start Date
2021-06-30
Completion Date
2028-03-31
Last Updated
2025-07-28
Healthy Volunteers
No
Interventions
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.
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.).
Locations (34)
University Hospital of Patras
Pátrai, AX, Greece
Ospedale C. e G. Mazzoni
Ascoli Piceno, AP, Italy
Ente ecclesiastico Ospedale Regionale Generale "F. Miulli"
Acquaviva delle Fonti, BA, Italy
Policlinico University Hospital
Bari, BA, Italy
Di Venere Hospital
Bari, BA, Italy
ASST Papa Giovanni XXIII
Bergamo, BG, Italy
Azienda Ospedaliera San Pio
Benevento, BN, Italy
Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola
Bologna, BO, Italy
ARNAS Brotzu
Cagliari, CA, Italy
P.O. San Giuseppe Moscati
Aversa, CE, Italy
Azienda Ospedaliera "Policlinico "G. Rodolico- San Marco"
Catania, CT, Italy
Azienda Ospedaliera Per L'emergenza Cannizzaro
Catania, CT, Italy
IRCCS Casa sollievo della sofferenza
San Giovanni Rotondo, FG, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
Misericordia Hospital
Grosseto, GR, Italy
Ospedale Vito Fazzi
Lecce, LE, Italy
Ospedale Santa Maria Goretti, Latina
Latina, LT, Italy
Azienda Ospedaliero Universitaria Policlinico "G. Martino", Messina
Messina, ME, Italy
Centro Cardiologico Monzino IRCCS
Milan, MI, Italy
IRCCS Galeazzi- Sant'Ambrogio
Milan, MI, Italy
San Camillo Hospital
Roma, RM, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
UOSA Cardiologia Interventistica
Siena, SI, Italy
P.O. Umberto I
Syracuse, SR, Italy
Struttura Complessa di Cardiologia Clinica e Interventistica
Sassari, SS, Italy
Rivoli Hospital
Rivoli, TO, Italy
Ospedale Conegliano
Conegliano, TV, Italy
Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital
Udine, UD, Italy
Federico II di Napoli
Naples, Italy
San Giovanni Hospital
Rome, Italy
Hospital Virgen de la Victoria
Málaga, MA, Spain
Hospital universitario La Princesa, Madrid
Madrid, M, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland