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

Primary Purpose

Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Optical coherence tomography
iFR/FFR/RFR
Sponsored by
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Optical coherence tomography, Vulnerable plaque

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of at least 18 years.
  • Diagnosis of acute coronary syndrome.
  • Single intermediate lesion in an intervention-naïve major coronary segment (diameter ≥2.5 mm) determining a 40-70% diameter stenosis at quantitative coronary angiography analysis 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.

Exclusion criteria:

  • Female with childbearing potential or lactating.
  • Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
  • Advanced heart failure (NYHA 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).
  • Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
  • Prior myocardial infarction or coronary artery bypass graft [CABG] or PCI revascularization in the target coronary vessel.
  • Coronary anatomy unsuitable for PCI.
  • Comorbidities that might interfere with completion of the study procedures.
  • Planned major surgery necessitating interruption of dual antiplatelet.
  • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.

Sites / Locations

  • San Giovanni HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermediate lesion OCT-based management

Intermediate lesion physiology-based management

Arm Description

At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following: 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). 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.

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.

Outcomes

Primary Outcome Measures

Number of patients with cardiac death or non-fatal spontaneous target-vessel myocardial infarction
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.

Secondary Outcome Measures

Number of patients with cardiac death
Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death.
Number of patients with non-fatal spontaneous target-vessel Myocardial infarction (excluding peri-procedural MI)
Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.
Number of patients with target lesion revascularization (either percutaneous or surgical)
Repeated lesion revascularization will be considered in case of repeated percutaneous coronary intervention and coronary artery bypass grafting the enrolled lesions.
Number of patients with composite of cardiac death and any myocardial infarction
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be collected regardless of the culprit vessel involved.
Number of patients with target vessel failure
Composite endpoint including cardiac death, non-fatal target-vessel MI, ischemia-driven target lesion revascularization.
Number of patients with composite endpoint of peri-procedural complications
contrast-induced nephropathy: a 25% increase in serum creatinine (SCr) from baseline or a 0.5 mg/dL (44 µmol/L) increase in absolute SCr value-within 48-72 hours after intravenous contrast administration. dissection requiring bail-out stenting. post-procedural MI: an increase within 48 hours after the index procedure of creatine kinase[CK]-MB (U/L) >5 times or Troponin (ng/L) >35 times above the normal value along with at least one of the followings: 1) symptoms of ischemia; 2) new or presumed new significant ST or T changes or new left bundle branch block; 3) new pathologic Q waves on an electrocardiogram; 4) new loss of viable myocardium or new regional wall motion abnormality; 5) reduced flow or major dissection in the coronary at angiography; or 6) intracoronary thrombus by angiography or autopsy. A stand-alone biomarker definition will be accepted in case of increase in the cardiac biomarker CK-MB >10 times or Troponin >70 times above the upper normal values.

Full Information

First Posted
July 10, 2021
Last Updated
August 24, 2021
Sponsor
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05027984
Brief Title
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Acronym
INTERCLIMA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
July 5, 2023 (Anticipated)
Study Completion Date
July 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro per la Lotta Contro l'Infarto - Fondazione Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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 (i.e. fractional flow reserve[FFR]/instantaneous Wave-Free Ratio[iFR]/resting full-cycle ratio[RFR]) 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 (FFR/iFR/RFR) 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 ≥2.5 mm) and fulfilling all inclusion/exclusion criteria will be eligible. Enrolled patients will be randomized 1:1 to either OCT or iFR/FFR/RFR 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 (i.e., minimum lumen area [MLA] <3.5 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 ≤0.89 or an FFR ≤0.80 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
Keywords
Coronary artery disease, Optical coherence tomography, Vulnerable plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: one group receiving functional assessment of intermediate coronary lesions and the other group undergoing OCT assessment.
Masking
Outcomes Assessor
Masking Description
All events included in the study endpoints will be adjudicated by a blinded Clinical Event Adjudication Committee.
Allocation
Randomized
Enrollment
1420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate lesion OCT-based management
Arm Type
Experimental
Arm Description
At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following: 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). 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.
Arm Title
Intermediate lesion physiology-based management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Optical coherence tomography
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
iFR/FFR/RFR
Intervention Description
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.).
Primary Outcome Measure Information:
Title
Number of patients with cardiac death or non-fatal spontaneous target-vessel myocardial infarction
Description
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of patients with cardiac death
Description
Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death.
Time Frame
2 years
Title
Number of patients with non-fatal spontaneous target-vessel Myocardial infarction (excluding peri-procedural MI)
Description
Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.
Time Frame
2 years
Title
Number of patients with target lesion revascularization (either percutaneous or surgical)
Description
Repeated lesion revascularization will be considered in case of repeated percutaneous coronary intervention and coronary artery bypass grafting the enrolled lesions.
Time Frame
2 years
Title
Number of patients with composite of cardiac death and any myocardial infarction
Description
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be collected regardless of the culprit vessel involved.
Time Frame
2 years
Title
Number of patients with target vessel failure
Description
Composite endpoint including cardiac death, non-fatal target-vessel MI, ischemia-driven target lesion revascularization.
Time Frame
2 years
Title
Number of patients with composite endpoint of peri-procedural complications
Description
contrast-induced nephropathy: a 25% increase in serum creatinine (SCr) from baseline or a 0.5 mg/dL (44 µmol/L) increase in absolute SCr value-within 48-72 hours after intravenous contrast administration. dissection requiring bail-out stenting. post-procedural MI: an increase within 48 hours after the index procedure of creatine kinase[CK]-MB (U/L) >5 times or Troponin (ng/L) >35 times above the normal value along with at least one of the followings: 1) symptoms of ischemia; 2) new or presumed new significant ST or T changes or new left bundle branch block; 3) new pathologic Q waves on an electrocardiogram; 4) new loss of viable myocardium or new regional wall motion abnormality; 5) reduced flow or major dissection in the coronary at angiography; or 6) intracoronary thrombus by angiography or autopsy. A stand-alone biomarker definition will be accepted in case of increase in the cardiac biomarker CK-MB >10 times or Troponin >70 times above the upper normal values.
Time Frame
Peri-procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of at least 18 years. Diagnosis of acute coronary syndrome. Single intermediate lesion in an intervention-naïve major coronary segment (diameter ≥2.5 mm) determining a 40-70% diameter stenosis at quantitative coronary angiography analysis 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. Exclusion criteria: Female with childbearing potential or lactating. Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl). Advanced heart failure (NYHA 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). Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries. Prior myocardial infarction or coronary artery bypass graft [CABG] or PCI revascularization in the target coronary vessel. Coronary anatomy unsuitable for PCI. Comorbidities that might interfere with completion of the study procedures. Planned major surgery necessitating interruption of dual antiplatelet. Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Prati, MD
Phone
+39 0677055330
Email
fprati61@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Prati, MD
Organizational Affiliation
Centro per la Lotta con l'Infarto - CLI Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Giovanni Hospital
City
Rome
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Prati, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

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