a Physician-inititated Trial Investigating the iVolution Nitinol Stent

NCT02430922 | Completed Phase 2 DMC

• 1 other identifier: FMRP-150106
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Serious adverse events until follow-up completions

  1,6,12 months and interem visits

Study Arms (1)

iVolution stent

EXPERIMENTAL

Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions.

Device: iVolution nitinol stent

Interventions

iVolution nitinol stent DEVICE

iVolution stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
• Patient presenting with a score from 2 to 4 according to the Rutherford classification
• Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
• Patient is \>18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
• 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
• The target lesion has angiographic evidence of stenosis or occlusion
• Length of the target lesion is ≤ 15 cm by visual estimation
• Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
• There is angiographic evidence of at least one vessel-runoff to the foot

You may not qualify if:

• Presence of a stent in the target vessel that was placed during a previous procedure
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Previous bypass surgery in the same limb
• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
• Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to nickel-titanium or other study device components
• Patients with uncorrected bleeding disorders
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than 12 months
• Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30%
• Use of thrombectomy, atherectomy or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

Heilig-Hart Ziekenhuis

Tienen, Flemish Brabant, 3300, Belgium

Location

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Marc Bosiers, MD

  Flanders Medical Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

BE (4)