Aorto-Iliacal Artheropathy
Conditions
Interventions
Group 1: Information for the patient on potential study participation, review of Inclusion and Exclusion criteria, patient consent, physical examination, blood parameters (if carried out) are queried
Sponsors
IVascular
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. = 18 years of age 2. Rutherford clinical stage 2 to 5 3. Atheromatous aorto-iliac lesions evidenced by duplex scan, CT angiography or arteriography. 4. De novo atheromatous lesion of the aortoiliac segment 5. Patient informed about the study and collection of the patient's informed consent agreement.
Exclusion criteria
Exclusion criteria: 1. Protected adult patients, guardianship, curatorship, safeguard of justice 2. Woman with possibility of pregnancy 3. Patient with asymptomatic atheromatous lesions 4. Patient with inflow lesion in the infrarenal aorta 5. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction) 6. Acute ischemia or acute thrombosis 7. Non-atherosclerotic disease 8. History of coagulopathy 9. Severe comorbidities with life expectancy <2 years 10. Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure 11. Patient participating in another clinical study which may interfere with the results 12. Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study 13. Lesion near or adjacent to an aneurysm 14. Inability to follow-up during the trial 15. Patient objection to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency of the stent at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary endpoints: Secondary: For assessment: - Technical success - Procedural success - Perioperative morbidity and mortality up to MI. - Primary sustained clinical improvement in MI, MG, Ml2 and M24. - Primary open rate on MG and M24. - Secondary patency rate on MG, Ml2 and M24. Target lesion revascularization: MG, Ml2 and M24. Target limb revascularization: MG, Ml2, and M24. Resting ankle-arm index at MI, MG, Ml2 and M24. | — |
Countries
Belgium, France, Germany, Spain
Contacts
Public ContactSara Pich
iVascular
Outcome results
None listed