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Peripheral Arterial DiseasePhase 4DUR-POPNCT01412450

Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions

A Phase 4 study testing nitinol stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
nitinol stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesBelgium
Study dates
Jul 2010to Aug 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • Imeldaziekenhuis

    Bonheiden, Antwerp, 2820

  • A.Z. Sint-Blasius

    Dendermonde, East-Flanders, 9200

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

  • Heilig-Hart Ziekenhuis

    Tienen, Flemish Brabant, 3300

Other trials in Belgium

About this study

Official title: DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions

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.

Being tested
nitinol stent
Keywords
symptomatic popliteal artery stenosis or occlusion
Medical subject headings
Peripheral Arterial Disease, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nitinol stentDevice

    Also called Protégé EverFlex stent

    implantation of one Protégé EverFlex stent

Study groups in NCT01412450
Study groupRoleWhat they receive
nitinol stentExperimentalProtégé EverFlex stent
Receives: Device: nitinol stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months post-procedure

Secondary outcomes (5)

  1. Technical success

    Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging

    Measured: 1 day post-procedure

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

    Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.

    Measured: 6-, 12-month follow-up

  3. Clinical success

    Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

    Measured: 6-, 12-month follow-up

  4. tent fracture rate at 12-month follow-up

    Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)

    Measured: 12-month follow-up

  5. Serious adverse events

    Defined as 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2011 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412450
Sponsor's protocol ID
FMRP-100702
Acronym
DUR-POP
Status last verified
Sep 2013
First submitted
2 Jul 2010
Last updated
1 Oct 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nitinol stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary patency (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01412450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.

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