Informations générales (source: ClinicalTrials.gov)
Innova Breeze®-Based Roadmap for Peripheral Arterial Disease (IBREED)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
janvier 2022
mai 2024
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Yann GOUEFFIC, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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