Clinical trial NCT01412450: Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
Official title: DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: symptomatic popliteal artery stenosis or occlusion
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2011-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

General Inclusion criteria

* 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

Angiographic Inclusion Criteria

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: primary patency
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Technical success
timeFrame: 1 day post-procedure
measure: Primary patency rate at 6-, 12-month follow-up.
timeFrame: 6-, 12-month follow-up
measure: Clinical success
timeFrame: 6-, 12-month follow-up
measure: tent fracture rate at 12-month follow-up
timeFrame: 12-month follow-up
measure: Serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
state: Antwerp
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
state: East-Flanders
city: Tienen
country: Belgium
facility: Heilig-Hart Ziekenhuis
state: Flemish Brabant
Study officials:
affiliation: A.Z. Sint-Blasius
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: