moderate to severe calcified stenosis or occlusion of the femoral and popliteal arteries
Conditions
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients over 18 years old • Moderate [=180° (both sides of vessel at same location) and less than one-half of the total lesion length] or severe [=180° (both sides of vessel at same location) and no less than one-half of the total lesion length] calcified lesion(s) defined by PARC calcification classification • Rutherford category grade 2 or above • Sign informed consent form • Treatment of patients with moderate to severe calcified SFA and/or PPA stenosis or occlusive disease using Eluvia, reference vessel diameter 4.0-6.0 mm.
Exclusion criteria
Exclusion criteria: • Life expectation less than 1 year • Use of IVL, atherectomy or other debulking devices in the target lesion during the index procedure • Bare metal stent(s) and/or covered stent(s) implanted in the target lesion during the index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle-brachial index(ABI) change rate at 3 months;Ankle-brachial index(ABI) change rate at 6 months;Ankle-brachial index(ABI) change rate at 12 months;Ankle-brachial index(ABI) change rate at 24 months;Ankle-brachial index(ABI) change rate at 36 months;Changes of Rutherford category at 3 months;Changes of Rutherford category at 6 months;Changes of Rutherford category at 12 months;Changes of Rutherford category at 24 months;Changes of Rutherford category at 36 months;Primary patency rate at 6 months;Primary patency rate at 36 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 3 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 6 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 12 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 24 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 36 months;Assisted primary patency rates at 6 months;Assisted primary patency rates at 12 months;Assisted primary patency rates at 36 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline at 3 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline at 6 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline at 12 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline at 24 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline at 36 months;Device adverse reactions (ADE) and serious adverse reactions (SADE) at 3 months after index procedure;Device adverse reactions (ADE) and serious adverse reactions (SADE) at 6 months after index procedure;Device adverse reactions (ADE) and serious adverse reactions (SADE) at 12 months after index procedure;Device adverse reactions (ADE) and serious adverse reactions (SADE) at 24 months after index procedure;Device adverse reactions (ADE) and serious adverse | — |
Countries
China
Contacts
Public ContactWeiguo Fu
Zhongshan Hospital, Fudan University
Outcome results
None listed