Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05189522
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-12
• Study Start: 2022-01-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Primary Completion: 2024-02-10
• Study Completion: 2024-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of iodinated contrast volume	Day 1	This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France