Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions

NCT01412450 | Completed Phase 4 DMC

• 1 other identifier: FMRP-100702
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.

Conditions

Peripheral Arterial Disease

Keywords

symptomatic popliteal artery stenosis or occlusion

Outcome Measures

Primary Outcomes (1)

• primary patency

  primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months

  12 months post-procedure

Secondary Outcomes (5)

• Technical success

  1 day post-procedure

• Primary patency rate at 6-, 12-month follow-up.

  6-, 12-month follow-up

• Clinical success

  6-, 12-month follow-up

• tent fracture rate at 12-month follow-up

  12-month follow-up

• Serious adverse events

  1 year

Study Arms (1)

nitinol stent

EXPERIMENTAL

Protégé EverFlex stent

Device: nitinol stent

Interventions

nitinol stent DEVICE

implantation of one Protégé EverFlex stent

Also known as: Protégé EverFlex stent

nitinol 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, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is \>18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Prior to enrollment, the guidewire has crossed target lesion
• Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent
• The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
• The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
• Target vessel diameter visually estimated is \>3.5mm and \<7.5 mm
• There is angiographic evidence of at least one-vessel-runoff to the foot

You may not qualify if:

• Presence of another stent in the target vessel that was placed during a previous procedure
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Previous by-pass surgery in the same limb
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Aneurysm located at the level of the SFA and/or popliteal artery
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure
• Use of thrombectomy, artherectomy 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 completed the entire follow up period.

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

Imeldaziekenhuis

Bonheiden, Antwerp, 2820, Belgium

Location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

Heilig-Hart Ziekenhuis

Tienen, Flemish Brabant, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Bites and Stings

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Marc Bosiers, MD

  A.Z. Sint-Blasius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: August 9, 2011
• Study Start: July 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

BE (4)