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)

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age of at least 18 years.

• Diagnosis of acute coronary syndrome.

• Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel.

• Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.

• Life expectancy \>3 years.

Locations
Other Locations
Greece
University Hospital of Patras
RECRUITING
Pátrai
Italy
Ente ecclesiastico Ospedale Regionale Generale F. Miulli
RECRUITING
Acquaviva Delle Fonti
Ospedale C. e G. Mazzoni
RECRUITING
Ascoli Piceno
P.O. San Giuseppe Moscati
RECRUITING
Aversa
Di Venere Hospital
RECRUITING
Bari
Policlinico University Hospital
RECRUITING
Bari
Azienda Ospedaliera San Pio
RECRUITING
Benevento
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola
RECRUITING
Bologna
ARNAS Brotzu
RECRUITING
Cagliari
Azienda Ospedaliera Per L'emergenza Cannizzaro
RECRUITING
Catania
Azienda Ospedaliera Policlinico G. Rodolico- San Marco
NOT_YET_RECRUITING
Catania
Ospedale Conegliano
RECRUITING
Conegliano
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Misericordia Hospital
RECRUITING
Grosseto
Ospedale Santa Maria Goretti, Latina
RECRUITING
Latina
Ospedale Vito Fazzi
RECRUITING
Lecce
Azienda Ospedaliero Universitaria Policlinico G. Martino, Messina
RECRUITING
Messina
Centro Cardiologico Monzino IRCCS
RECRUITING
Milan
IRCCS Galeazzi- Sant'Ambrogio
RECRUITING
Milan
Federico II di Napoli
RECRUITING
Napoli
Rivoli Hospital
RECRUITING
Rivoli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
San Camillo Hospital
RECRUITING
Roma
San Giovanni Hospital
RECRUITING
Rome
IRCCS Casa sollievo della sofferenza
RECRUITING
San Giovanni Rotondo
Struttura Complessa di Cardiologia Clinica e Interventistica
NOT_YET_RECRUITING
Sassari
UOSA Cardiologia Interventistica
RECRUITING
Siena
P.O. Umberto I
RECRUITING
Syracuse
Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital
RECRUITING
Udine
Spain
Hospital universitario La Princesa, Madrid
RECRUITING
Madrid
Hospital Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Switzerland
Inselspital, Bern University Hospital
RECRUITING
Bern
Contact Information
Primary
Francesco Prati, MD
fprati61@gmail.com
+39 0677055330
Backup
Flavio Giuseppe Biccirè, MD, PhD
flaviobiccire@gmail.com
Time Frame
Start Date: 2021-06-30
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 1420
Treatments
Experimental: Intermediate lesion OCT-based management
At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following:~1. FCT \<75 µm, plus at least 2 of 3 other OCT criteria of plaque vulnerability (i.e., MLA \<3.5 mm2, lipid arc with circumferential extension \>180°, and the presence of macrophages).~2. The presence of intracoronary thrombus at a non-culprit site, irrespective of the presence of other vulnerability criteria, may prompt treatment with DES, at the operator's discretion.~All lesions fulfilling these interventional criteria will be treated with an OCT guided DES implantation in order to achieve an optimal stent implantation.~In presence of a MLA \<2.0 mm2, best cut-off showing correlation with fractional-flow reserve positive functional (FFR) assessment, clinical decision whether to treat the lesion will be based on FFR assessment irrespective of the presence of other criteria of vulnerability. Alternatively authors will have the option to treat the lesion with a DES.
Active_comparator: Intermediate lesion physiology-based management
The iFR/FFR/RFR measurements will be obtained using a coronary-pressure guidewire. For FFR, hyperemia will be induced with the administration of intravenous adenosine, in accordance with the clinical practice at each participating center. Lesion features prompting intervention instead of conservative medical approach will be the following: iFR ≤0.89, or FFR ≤0.80.(32) All lesions fulfilling these interventional criteria will be treated with an FFR guided DES implantation. PCI will be performed with the aim of achieving a post-stenting FFR ≥0.90 (i.e. optimal FFR result). If post-stenting FFR was \<0.90 a further post-dilation of the stent could be performed and if FFR remained at \<0.90, a pullback of the wire to identify another possible pressure drop and/or a subsequent stent implantation at least 5 mm from the stent will be performed according to physician's preference.
Sponsors
Collaborators: Abbott Vascular (Santa Clara, USA)
Leads: Centro per la Lotta Contro l'Infarto - Fondazione Onlus

This content was sourced from clinicaltrials.gov