Peripheral Arterial Disease
Conditions
Brief summary
The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.
Interventions
DEVICEiVolution nitinol stent
Sponsors
Flanders Medical Research Program
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment 2. Patient presenting with a score from 2 to 4 according to the Rutherford classification 3. Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals 4. Patient is \>18 years old 5. Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study 6. Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint 7. The target lesion has angiographic evidence of stenosis or occlusion 8. Length of the target lesion is ≤ 15 cm by visual estimation 9. Target vessel diameter visually estimated is ≥4 mm and ≤7 mm 10. There is angiographic evidence of at least one vessel-runoff to the foot
Exclusion criteria
1. Presence of a stent in the target vessel that was placed during a previous procedure 2. Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis 3. Previous bypass surgery in the same limb 4. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics 5. Patients who exhibit persistent acute intraluminal thrombus at the target lesion site 6. Perforation at the angioplasty site evidenced by extravasation of contrast medium 7. Patients with known hypersensitivity to nickel-titanium or other study device components 8. Patients with uncorrected bleeding disorders 9. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding 10. Life expectancy of less than 12 months 11. Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30% 12. Use of thrombectomy, atherectomy or laser devices during procedure 13. Any patient considered to be hemodynamically unstable at onset of procedure 14. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency at 12 months | 12 months | freedom from \>50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Procedure | — |
| Primary Patency at 1 & 6 months | 1 & 6 months | — |
| Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months | at all follow-up visits | — |
| Clinical Success at 1, 6 and 12 months | at all follow-up visits | Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- & 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification. |
| Serious adverse events until follow-up completions | 1,6,12 months and interem visits | Any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. |
Countries
Belgium
Outcome results
None listed