Status:
UNKNOWN
Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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. G...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 25 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05189522
Start Date
January 26 2022
End Date
May 25 2024
Last Update
March 7 2023
Active Locations (1)
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1
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014