Usefulness of the Use of Co-registration Strategy With iFR in Long and/or Diffuse Coronary Lesions (iLARDI)

Randomized controlled trial to determinate if the physiological iFR pullback evaluation with Syncvision software (intervention group) could be useful in the reduction of stent length implanted, with the potencial benefit in terms of MACEs reduction at follow-up with respect to angiographic guiding of percutaneous coronary intervention (control group).

Study Overview

• Status: Active, not recruiting
• Conditions: Instantaneous Wave Free Ratio; Diffuse Coronary Artery Disease; Long Coronary Lesion; Syncvision Software
• Intervention / Treatment: Device: iFR pullback with Syncvision software (Volcano company)

Detailed Description

Physiological coronary lesion evaluation is actually a routine practice in the labs to guide percutaneous coronary intervention decision making. Unlike FFR, the new index permit us to perform an analysis of the physiological importance of every lesion and every coronary segment. This fact has allowed to create a new specific software. Syncvision show us the functional compromise of every lesion and predict the expected IFR improvement.

This potential benefit could have an extra benefit in the reduction of the implanted stent length. There are some observational study published that reported a reduction of 5 mm of stent length, but we think that the reduction could be significantly higher.

However, this reduction could be detrimental of the complete cover of plaque in this type of lesion, which has also proved to be a predictor of MACEs.

For this reason, we have proposed to perform a randomized study to define if the utilization of physiological IFR pullback evaluation in long and/or diffuse coronary lesion present advantages over classical angiographic PCI.

Study hyphotesis:

Revascularization guided by IFR-Pullback in long and/or diffuse coronary lesions permit to reduce the stent length implanted, with the potential benefit in terms of MACEs reduction.

Study design:

Randomized and controlled study where we will include patients with significant coronary stenosis at least in one vessel and a total lesion length higher than 30 mm in the different clinical scenarios (stable angina, NSTEMI and STEMI in non-culprit lesion).

In the control group, stent length will be decided by the operator. In the iFR-pullback group, stent length will be decided in base to iFR expected, trying to obtain an IFR of 0.90 with the minimum stent length as possible.

The expected stent length reduction is 15 mm (primary endpoint). As secondary endpoint, we will analyze the combined endpoint of myocardial infarction, death and new revascularization).

The sample size in base to primary endpoint will be of 100 patients.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age higher than 18 years old.
• Sign of inform consent
• Patients with at least a vessel with angiographic significant lesion (long/sequential or diffuse lesion) >/= 25 mm of length where the percutaneous strategy is going to be the choice strategy.
• Patients with stable angina, NSTEMI or STEMI (non culprit vessel)

Exclusion Criteria:

• Patients with Acute Coronary Syndrome with non optimal result of culprit vessel (final TIMI flow < TIMI III, non-reflow phenomenon during the treatment, residual coronary dissection, lost or compromise of significant side branch).
• Acute Coronary Syndrome and Left Ventricular Ejection Fraction lower than 45%.
• Live expectancy lower than 12 months.
• Patients with severe aortic stenosis.
• Contraindication for dual anti platelet therapy during at least 12 months.
• Patients with indication of bypass surgery in base to Heart Team decision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Long/diffuse coronary lesion should be evaluated and guided by iFR pullback with Syncvision software to achieve a final iFR of 0.90	Device: iFR pullback with Syncvision software (Volcano company); iFR pullback with Syncvision software permit us to analyze the vessel completely and to predict the physiological significance of every lesion and segment, to predict the benefit of the revascularization in terms of iFR improvement, and to predict the minimum stent length necessary to achieve this improvement.
No Intervention: Control group; Long/diffuse coronary lesion should be treated guided by angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the average stent length implanted in the Syncvision guided group	Reduction of stent length implanted, measured in millimeters, in the group guided by Syncvision software	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint of cardiac death, myocardial infarction and new revascularization of analyzed or treated vessel in the basal procedure at 12 months of follow-up	12 months

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Investigators: Principal Investigator: Francisco Hidalgo, PhD, Hospital Universitario Reina Sofia

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Estimated): January 24, 2024
• Study Completion (Estimated): January 24, 2024

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diffuse coronary artery disease; Instantaneous Wave Free Ratio; Long coronary lesion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: iLARDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The shared documents will be available after the publication for 1 year.
• IPD Sharing Access Criteria: By e-mail to uicec@imibic.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No