Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEInnova 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
OTHERControl 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.
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of iodinated contrast volume | Day 1 | This outcome corresponds to the volume of iodinated contrast used at the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Estimation of renal function at 1 month | Month 1 | This outcome corresponds to the Glomerular filtration rate (GFR) |
Countries
France
Contacts
Primary ContactYann GOUEFFIC, MD
Backup ContactHelene BEAUSSIER, PharmD, PhD
Outcome results
None listed