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Peripheral Vascular DiseasePhase 44-EVERNCT01413139

4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

A Phase 4 study testing 4F portfolio products from Biotronik in people with Peripheral Vascular Disease and Claudication, run by Flanders Medical Research Program at 5 sites in 2 countries.

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

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease, Claudication
What is being tested?
4F portfolio products from Biotronik
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesin 2 countries
Study dates
Jul 2010to Sep 2013
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

  • De novo, restenotic or reoccluded 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 to comply with specified follow-up evaluations at the predefined time intervals times
  • 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
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  • Patient is eligible for treatment with 4F compatible devices
  • Angiographic Inclusion Criteria:
  • The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
  • The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
  • Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
  • Target vessel diameter visually estimated is =4 mm and =6.5 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 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
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  • Patients with known hypersensitivity to nickel-titanium
  • 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 planned surgical intervention/procedure 30 days after the study 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Belgium3 sites

  • Imelda hospital

    Bonheiden, Antwerpen, 2820

  • AZ Sint Blasius

    Dendermonde, Oost-Vlaanderen, 9200

  • Universitair ziekenhuis antwerpen

    Edegem, Antwerpen, 2650

Other trials in Belgium

Germany2 sites

  • Park-Krankenhaus Leipzig

    Leipzig, 04289

  • St Fransiskus hospital

    Münster, 48145

Other trials in Germany

About this study

Official title: 4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.

The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).

Being tested
4F portfolio products from Biotronik
Keywords
peripheral Vascular Disease, claudication, rest pain
Medical subject headings
Peripheral Vascular Diseases, Intermittent Claudication

What participants receive

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

  • 4F portfolio products from BiotronikDevice

    Also called Astron pulsar, Astron Pulsar-18, Fortress, Passeo-18

    4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18

Study groups in NCT01413139
Study groupRoleWhat they receive
4F portfolio products from BiotronikOtherThe devices under investigation are the 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18 and Cruiser-18.
Receives: Device: 4F portfolio products from Biotronik

What is being measured

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

  1. Primary patency 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

    Primary patency at 12 months, defined as freedom from >50% restenosis

    Measured: 12 months

Secondary outcomes (5)

  1. Technical success

    Technical success, defined as the ability to cross and stent 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. Puncture site complications

    Number of puncture site complications in the absence of a closure device after intervention

    Measured: 10 days

  3. Primary patency

    Primary patency rate at 6- \& 24-month follow-up, defined as freedom from >50% restenosis at 6 \& 24 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention.

    Measured: 6- & 24-month follow-up

  4. Clinical success

    Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12- \& 24-month follow-up of one class or more as compared to the pre-procedure

    Measured: 6-, 12- & 24-month follow-up

  5. Stent fracture rate at 12- & 24-month follow-up

    Stent fracture rate at 12- \& 24-month follow-up (in patient who were treated with stentplacement), as determined according the following classification on x-ray:

    1. Class 0 : no strut factures
    2. Class I : single tine fracture
    3. Class II : multiple tine factures
    4. Class III : Stent fracture(s) with preserved alignment of the components
    5. Class IV : Stent fracture(s) with mal-alignment of the components
    6. Class V : Stent fracture(s) in a trans-axial spiral configuration

    Measured: 12- & 24-month follow-up

Timeline

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

  1. First posted10 Aug 2011 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2011
  4. Study completionSep 2013

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01413139
Sponsor's protocol ID
FMRP-100701
Acronym
4-EVER
Status last verified
Sep 2013
First submitted
1 Jul 2010
Last updated
1 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Bosiers M, Deloose K, Callaert J, Keirse K, Verbist J, Hendriks J, Lauwers P, D'Archambeau O, Scheinert D, Torsello G, Peeters P. 4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013 Dec;20(6):746-56. doi: 10.1583/13-4437MR.1.

    PubMed 24325689

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 4F portfolio products from Biotronik in people with Peripheral Vascular Disease and Claudication, run by Flanders Medical Research Program at 5 sites in 2 countries.

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 5 sites in Belgium, Germany. 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 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 (time frame: 12 months). 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 NCT01413139, which also lists 1 linked publication.

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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