Actively Recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Led by Centro per la Lotta Contro l'Infarto - Fondazione Onlus · Updated on 2025-07-28
1420
Participants Needed
34
Research Sites
352 weeks
Total Duration
On this page
Sponsors
C
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Lead Sponsor
A
Abbott Vascular (Santa Clara, USA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) with 40-70% diameter stenosis by visual assessment and no other significant stenosis (>70%) in the same vessel.
- Patient informed of the nature of the study, agrees to participate, and provides written informed consent as approved by the Ethics Committee.
- Life expectancy greater than 3 years.
You will not qualify if you...
- Female with childbearing potential or lactating.
- Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl).
- Advanced heart failure (New York Heart Association Class III-IV).
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
- Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
- Lesions located in the left main coronary artery.
- Diffusely diseased coronary artery segment or presence of one or more significant untreated non-culprit lesions in the coronary arteries.
- Prior myocardial infarction or coronary artery bypass graft or PCI revascularization in the target coronary vessel.
- Coronary anatomy unsuitable for PCI.
- Comorbidities that might interfere with completion of study procedures.
- Planned major surgery requiring interruption of dual antiplatelet therapy.
- Participation in another investigational drug or device trial that has not completed the primary endpoint or would interfere with this study's endpoints.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 34 locations
1
University Hospital of Patras
Pátrai, AX, Greece, 26504
Actively Recruiting
2
Ospedale C. e G. Mazzoni
Ascoli Piceno, AP, Italy, 63100
Actively Recruiting
3
Ente ecclesiastico Ospedale Regionale Generale "F. Miulli"
Acquaviva delle Fonti, BA, Italy, 70021
Actively Recruiting
4
Policlinico University Hospital
Bari, BA, Italy, 70120
Actively Recruiting
5
Di Venere Hospital
Bari, BA, Italy, 70131
Actively Recruiting
6
ASST Papa Giovanni XXIII
Bergamo, BG, Italy, 24127
Actively Recruiting
7
Azienda Ospedaliera San Pio
Benevento, BN, Italy, 82100
Actively Recruiting
8
Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
9
ARNAS Brotzu
Cagliari, CA, Italy, 09047
Actively Recruiting
10
P.O. San Giuseppe Moscati
Aversa, CE, Italy, 81031
Actively Recruiting
11
Azienda Ospedaliera "Policlinico "G. Rodolico- San Marco"
Catania, CT, Italy, 95123
Not Yet Recruiting
12
Azienda Ospedaliera Per L'emergenza Cannizzaro
Catania, CT, Italy, 95126
Actively Recruiting
13
IRCCS Casa sollievo della sofferenza
San Giovanni Rotondo, FG, Italy, 71013
Actively Recruiting
14
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy, 16132
Actively Recruiting
15
Misericordia Hospital
Grosseto, GR, Italy, 58100
Actively Recruiting
16
Ospedale Vito Fazzi
Lecce, LE, Italy, 73100
Actively Recruiting
17
Ospedale Santa Maria Goretti, Latina
Latina, LT, Italy, 04100
Actively Recruiting
18
Azienda Ospedaliero Universitaria Policlinico "G. Martino", Messina
Messina, ME, Italy, 98124
Actively Recruiting
19
Centro Cardiologico Monzino IRCCS
Milan, MI, Italy, 20138
Actively Recruiting
20
IRCCS Galeazzi- Sant'Ambrogio
Milan, MI, Italy, 20157
Actively Recruiting
21
San Camillo Hospital
Roma, RM, Italy, 00152
Actively Recruiting
22
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
23
UOSA Cardiologia Interventistica
Siena, SI, Italy, 53100
Actively Recruiting
24
P.O. Umberto I
Syracuse, SR, Italy, 96100
Actively Recruiting
25
Struttura Complessa di Cardiologia Clinica e Interventistica
Sassari, SS, Italy, 07100
Not Yet Recruiting
26
Rivoli Hospital
Rivoli, TO, Italy, 10098
Actively Recruiting
27
Ospedale Conegliano
Conegliano, TV, Italy, 31015
Actively Recruiting
28
Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital
Udine, UD, Italy, 33100
Actively Recruiting
29
Federico II di Napoli
Naples, Italy, 80138
Actively Recruiting
30
San Giovanni Hospital
Rome, Italy, 00184
Actively Recruiting
31
Hospital Virgen de la Victoria
Málaga, MA, Spain, 29010
Actively Recruiting
32
Hospital universitario La Princesa, Madrid
Madrid, M, Spain, 28006
Actively Recruiting
33
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
34
Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
Research Team
F
Francesco Prati, MD
CONTACT
F
Flavio Giuseppe Biccirè, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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