a Physician-inititated Trial Investigating the iVolution Nitinol Stent

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: iVolution nitinol stent

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Imelda Hospital
  • East-Flanders
    • Dendermonde, East-Flanders, Belgium, 9200
      • A.Z. Sint-Blasius
  • Flemish Brabant
    • Tienen, Flemish Brabant, Belgium, 3300
      • Heilig-Hart Ziekenhuis
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • OLV Aalst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iVolution stent; Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions.	Device: iVolution nitinol stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, Flanders Medical Research Program

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FMRP-150106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided