Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05027984
Status:
RECRUITING
Last Update Posted:
2021-08-31
First Post:
2021-07-10
Brief Title:
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Sponsor:
Centro per la Lotta Contro lInfarto - Fondazione Onlus
Organization:
Centro per la Lotta Contro lInfarto - Fondazione Onlus
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERCLIMA
Brief 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 ie fractional flow reserveFFRinstantaneous Wave-Free RatioiFRresting full-cycle ratioRFR treatment of intermediate 40-70 diameter stenosis at quantitative coronary angiography non-culprit coronary lesions in acute coronary syndrome ACS patients undergoing coronary angiography About 1400 patients with ACS will be randomized into the study at approximately 40 sites worldwide
Detailed Description:
The optimal strategy in patients with intermediated stenosis 40-70 diameter stenosis at coronary angiography is currently under debate Pure angiographic stenosis evaluation is often inadequate and alternative assessments of coronary plaques entered the clinical practice such as functional assessment FFRiFRRFR and intravascular imaging OCT and intravascular ultrasound IVUS Based on preliminary data current American College of Cardiology ACC and American Heart Association AHA revascularization guidelines recommend the use of flow fractional reserve FFR class IIa of evidence to assess angiographic intermediate coronary lesions in patients with stable ischemic heart disease and guide intervention However controversial data has recently emerged on the role of functional assessment of intermediate coronary lesions in both acute and chronic setting On the other hand in recent studies the presence of coronary plaques with vulnerability criteria at OCT identified patients at high risk of cardiac mortality and target vessel MI This study aims to assess the clinical effectiveness of an OCT-based strategy to guide revascularization in non-culprit intermediate coronary stenosis in patients with acute coronary syndrome ACS on the basis of the presence of morphological markers of plaque vulnerability Patients with single intermediate coronary lesion in a non-culprit intervention-naïve major coronary segment diameter 25 mm and fulfilling all inclusionexclusion criteria will be eligible Enrolled patients will be randomized 11 to either OCT or iFRFFRRFR based treatment In the OCT-guided arm non-culprit intermediate lesions will be treated with percutaneous coronary intervention PCI with implantation of a second-generation drug eluting stent DES when a fibrous cap thickness FCT 75 µm plus at least 2 of 3 other OCT criteria of plaque vulnerability ie minimum lumen area MLA 35 mm2 lipid arc with circumferential extension 180 and the presence of clusters of macrophages are detected by OCT In the absence of the above-mentioned 4 vulnerability criteria interventional procedures will be deferred regardless the observed MLA In the physiology-guided arm non-culprit intermediate lesions will be treated with PCI with implantation of a second-generation DES when an iFR or RFR 089 or an FFR 080 are measured otherwise interventional procedures will be deferred The primary endpoint a composite of cardiac death and target vessel spontaneous myocardial infarction will be assessed after 2 and 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None