a Physician-inititated Trial Investigating the iVolution Nitinol Stent

NCT ID: NCT02430922

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iVolution stent

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

Group Type: EXPERIMENTAL

iVolution nitinol stent

Intervention Type: DEVICE

Interventions

iVolution nitinol stent

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

Flanders Medical Research Program

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

A.Z. Sint-Blasius

Dendermonde, East-Flanders, Belgium

Heilig-Hart Ziekenhuis

Tienen, Flemish Brabant, Belgium

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

FMRP-150106

Identifier Type: -

Identifier Source: org_study_id