Clinical trial NCT05189522: Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
Official title: Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Amount of iodinated contrast volume
timeFrame: Day 1
Secondary outcomes:
measure: Patient safety in terms of radiation exposure at the end of the procedure
timeFrame: Day 1
measure: Staff safety in terms of radiation exposure at the end of the procedure
timeFrame: Day 1
measure: Patient clinical improvement
timeFrame: Month 1
measure: Estimation of renal function post-operative
timeFrame: Day 4
measure: Estimation of renal function at 1 month
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Yann GOUEFFIC, MD
role: PRINCIPAL_INVESTIGATOR
References:
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