Clinical trial NCT02430922: a Physician-inititated Trial Investigating the iVolution Nitinol Stent
Official title: EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2015-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Patency at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Technical Success
timeFrame: Procedure
measure: Primary Patency at 1 & 6 months
timeFrame: 1 & 6 months
measure: Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months
timeFrame: at all follow-up visits
measure: Clinical Success at 1, 6 and 12 months
timeFrame: at all follow-up visits
measure: Serious adverse events until follow-up completions
timeFrame: 1,6,12 months and interem visits
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
state: East-Flanders
city: Tienen
country: Belgium
facility: Heilig-Hart Ziekenhuis
state: Flemish Brabant
city: Aalst
country: Belgium
facility: OLV Aalst
state: Oost-Vlaanderen
Study officials:
affiliation: Flanders Medical Research Program
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: