NCT04283734

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

February 22, 2020

Last Update Submit

September 29, 2023

Conditions

Instantaneous Wave Free RatioDiffuse Coronary Artery DiseaseLong Coronary LesionSyncvision Software

Keywords

Diffuse coronary artery diseaseInstantaneous Wave Free RatioLong coronary lesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

Long/diffuse coronary lesion should be treated guided by angiography

Interventions

iFR pullback with Syncvision software (Volcano company)DEVICE

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Related Publications (1)

  • Hidalgo F, Gonzalez-Manzanares R, Suarez de Lezo J, Gallo I, Alvarado M, Perea J, Maestre-Luque LC, Resua A, Romero M, Lopez-Benito M, Perez de Prado A, Ojeda S, Pan M. The Usefulness of Coregistration with iFR in Tandem or Long Diffuse Coronary Lesions: The iLARDI Randomized Clinical Trial. J Clin Med. 2024 Jul 25;13(15):4342. doi: 10.3390/jcm13154342.

    PMID: 39124613DERIVED

Study Officials

  • Francisco Hidalgo, PhD

    Hospital Universitario Reina Sofía

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2020

First Posted

February 25, 2020

Study Start

February 11, 2020

Primary Completion

January 24, 2024

Study Completion

January 24, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The shared documents will be available after the publication for 1 year.
Access Criteria
By e-mail to uicec@imibic.org

Locations

ES(1)