a Physician-inititated Trial Investigating the iVolution Nitinol Stent

Peripheral Arterial Disease Clinical Trial

Official title:

EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430922
• Other study ID #: FMRP-150106
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• iVolution nitinol stent

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	Oost-Vlaanderen
Belgium	Imelda Hospital	Bonheiden	Antwerp
Belgium	A.Z. Sint-Blasius	Dendermonde	East-Flanders
Belgium	Heilig-Hart Ziekenhuis	Tienen	Flemish Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency at 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	12 months
Secondary	Technical Success		Procedure
Secondary	Primary Patency at 1 & 6 months		1 & 6 months
Secondary	Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months		at all follow-up visits
Secondary	Clinical Success at 1, 6 and 12 months	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.	at all follow-up visits
Secondary	Serious adverse events until follow-up completions	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.	1,6,12 months and interem visits