NCT05027984: INTERCLIMA

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

Recruiting now NA Last updated 28 July 2025

What this trial tests

NA trial testing Optical coherence tomography in Coronary Artery Disease in 1,420 participants. Currently enrolling.

Timeline

30 June 2021

Primary endpoint
31 March 2026

31 March 2028

Quick facts

Lead sponsor	Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,420
Start date	30 June 2021
Primary completion	31 March 2026
Estimated completion	31 March 2028
Sites	34 locations across Italy, Switzerland, Greece, Spain

Drugs / interventions tested

• Optical coherence tomography
• iFR/FFR/RFR

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Coronary Disease — all drugs for Coronary Disease →
• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →

Sponsor

Centro per la Lotta Contro l'Infarto - Fondazione Onlus

Who can join

18 and older, any sex, with Coronary Artery Disease or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Hybrid Intracoronary Imaging Technologies and Their Applications in Clinical Practice and Research.
   Tufaro V, Jaffer FA, Serruys PW, Onuma Y, et al · · 2024 · cited 19× · PMID 39260958 · DOI 10.1016/j.jcin.2024.07.007
2. Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial.
   Del Val D, Berta B, Roleder T, Malinowski K, et al · · 2024 · cited 14× · PMID 38840580 · DOI 10.4244/eij-d-23-00628
3. Physiology Versus Imaging-Guided Revascularization: Where Are We in 2023?
   Yang S, Koo BK. · · 2023 · cited 7× · PMID 37396425 · DOI 10.1016/j.jacasi.2023.03.009
4. Fractional Flow Reserve versus Angiography-Guided Management of Coronary Artery Disease: A Meta-Analysis of Contemporary Randomised Controlled Trials.
   Maznyczka AM, Matthews CJ, Blaxill JM, Greenwood JP, et al · · 2022 · cited 7× · PMID 36498667 · DOI 10.3390/jcm11237092
5. Advances in the Detection and Management of Vulnerable Coronary Plaques.
   Spagnolo M, Giacoppo D, Laudani C, Greco A, et al · · 2025 · cited 5× · PMID 40718929 · DOI 10.1161/circinterventions.125.015529
6. Exploring new insights in coronary lesion assessment and treatment in patients with diabetes mellitus: the impact of optical coherence tomography.
   Hommels TM, Hermanides RS, Fabris E, Kedhi E. · · 2023 · cited 5× · PMID 37226183 · DOI 10.1186/s12933-023-01844-1
7. Association of vessel fractional flow reserve (vFFR) with luminal obstruction and plaque characteristics as detected by optical coherence tomography (OCT) in patients with NSTE-ACS: the FAST OCT study.
   Ziedses des Plantes AC, Scoccia A, Groenland FTW, Tovar Forero MN, et al · · 2024 · cited 4× · PMID 39192480 · DOI 10.1093/ehjci/jeae212
8. Management of Coronary Vulnerable Plaque With Medical Therapy or Local Preventive Percutaneous Coronary Intervention.
   Kim H, Ahn JM, Kang DY, Lee J, et al · · 2024 · cited 3× · PMID 39100699 · DOI 10.1016/j.jacasi.2024.04.001