Innova Breeze®-Based Roadmap for Peripheral Arterial Disease (IBREED)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function.

The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient ≥ 18 years
  • Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6)
  • Patients with indication of femoropopliteal revascularization according the European guidelines (1)
  • Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
  • French-speaking patient
  • Patient is affiliated to the Social Security or equivalent system
  • Patients is able and willing to give free, informed and express oral consent
  • Iliac and/or below the knee lesions are allowed in combination to femoropopliteal lesions

Exclusion Criteria:

  • Upper limb approach
  • Femoral antegrade approach
  • Pregnant or breastfeeding woman
  • Adult under guardianship or trusteeship
  • Iodinated contrast allergy
  • Reduction in estimated Glomerular Filtration Ratio (eGFR) ≤ 29 ml/min/m2 (11)
  • Patients included in other studies which interact with intraoperative imaging protocols
  • Concurrent participation in an interventional (drug or device) study for which the follow-up period is not complete.
  • Patient under tutorship or curatorship
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Innova Breeze®-based roadmap

An Innova Breeze® bolus chase acquisition is realized prior to the revascularization to assess the lesions of the entire target limb. Guidance to the different lesions is done using a 2D roadmap based on the Innova Breeze® bolus acquisition frames if the patient position has not moved on the table.

An Innova Breeze® bolus chase acquisition is realized to assess the final result of the revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.

DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. Innova Breeze® bolus chase acquisitions are performed with the injector set at 4mL/s and the volume at 24mL (pressure limit 1000psi). An injector with iodinated contrast (50% of dilution) will be used.
Device: Innova Breeze®-based roadmap
An Innova Breeze® bolus chase acquisition is realized to assess the final result of the Revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm
Other: control group

2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence.

After treatment overall limb assessment will be done through multiple staged DSA.

Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.

DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used.

For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.
Other: Control Group

2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence.

After treatment overall limb assessment will be done through multiple staged DSA.

Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.

DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used.

For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of iodinated contrast volume
Time Frame: Day 1
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient safety in terms of radiation exposure at the end of the procedure
Time Frame: Day 1
This outcome corresponds to the number of DSA runs.
Day 1
Staff safety in terms of radiation exposure at the end of the procedure
Time Frame: Day 1
This outcome corresponds to the Operator exposure (Sv).
Day 1
Patient clinical improvement
Time Frame: Month 1
This outcome corresponds to the clinical status (Rutherford stage).
Month 1
Estimation of renal function post-operative
Time Frame: Day 4
This outcome corresponds to the Glomerular filtration rate (GFR).
Day 4
Estimation of renal function at 1 month
Time Frame: Month 1
This outcome corresponds to the Glomerular filtration rate (GFR)
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Yann GOUEFFIC, MD, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Anticipated)

February 10, 2024

Study Completion (Anticipated)

May 25, 2024

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBREED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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