Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

Official Title
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Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Innova Breeze®-based roadmap
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Innova Breeze®-based roadmap<br>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<br>* 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<br>|
| Other: control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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