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Peripheral Arterial DiseasePhase 2/3PES-BTK-70NCT01630070

Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries

A Phase 2/3 study testing Self-expandable drug eluting stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 5 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

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. 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?
Self-expandable drug eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
5 sitesBelgium
Study dates
Jan 2012to Oct 2014
Phase
Phase 2/3
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

  • Patient presenting with rest pain or minor tissue loss (Rutherford Clinical Category 4 or 5)
  • Patient is willing to comply with specified follow-up evaluations at the specified times
  • Patient is >18 years old
  • Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient has a projected life-expectancy of at least 12 months
  • Patient is eligible for treatment with a Self-Expanding Paclitaxel-Eluting stent
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  • Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
  • Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography
  • Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm
  • Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot.
  • Guidewire successfully traversed lesion
  • Length of target lesion is <50mm

Who cannot join

  • Untreated flow-limiting inflow lesions
  • Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
  • Has had a previous peripheral bypass affecting the target limb
  • Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
  • Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used
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  • Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated
  • Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion
  • Life expectancy of less than 12 months
  • Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints
  • Patient has other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention
  • Has end-stage renal disease defined as undergoing hemodialysis for kidney failure
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
  • Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT)type II
  • Treatment of ipsilateral non-study inflow lesions with other materials than regular guidewires, regular PTA balloons, bare metal stents and/or paclitaxel-coated stents
  • Additional treatments of the study lesion requiring materials/procedures other than standard guidewires, regular PTA balloons and/or a Self-Expanding Paclitaxel-Eluting stent (e.g. thrombectomy, re-entry catheters, CTO-wires, cutting balloon, cryoballoon, etc)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • OLV Ziekenhuis

    Aalst, East-Flanders, 9300

  • Imelda Hospital

    Bonheiden, Antwerp, 2820

  • AZ Sint-Blasius

    Dendermonde, East-Flanders, 9200

  • UZA

    Edegem, Antwerp, 2650

  • RZ Heilig-Hartziekenhuis

    Tienen, Antwerp, 3300

Other trials in Belgium

About this study

Official title: A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.

Being tested
Self-expandable drug eluting stent
Keywords
Critical limb ischemia, Rest pain, Minor tissue loss, Below the knee
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

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

  • Self-expandable drug eluting stentDevice

    Also called Self-Expanding Paclitaxel-Eluting stent

    Self-Expanding Paclitaxel-Eluting stent

Study groups in NCT01630070
Study groupRoleWhat they receive
Self-expandable drug eluting stentExperimentalSelf-Expanding Paclitaxel-Eluting stent
Receives: Device: Self-expandable drug eluting stent

What is being measured

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

  1. Primary patency

    Primary patency rate at 6 months, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤2.0 at the target lesion(s) with no clinically-driven reintervention within the treated segment, verified by Core Lab

    Measured: 6 months

  2. Primary patency

    Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography, verified by Core Lab

    Measured: 12 months

Secondary outcomes (10)

  1. Technical success

    Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment

    Measured: procedure (day 0)

  2. Procedural success

    Procedural success, defined as the ability to achieve <30% final residual stenosis of the target lesion by visual estimation (angio) and the absence of any in-hospital Major Adverse Events (MAE, defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, and all-cause mortality)

    Measured: Procedure (day 0)

  3. MAE (Major Adverse Event)

    MAE at 1, 6 and 12 months

    Major Adverse Events (MAE) include (but are not limited to)

    • death
    • myocardial infarction
    • stroke
    • emergent surgical revascularization of the target vessel
    • repeat vascularization of the target vessel
    • major amputation
    • bleeding complication requiring transfusion

    Measured: 1, 6 and 12 months

  4. SAE (Serious Adverse Event)

    Other SAEs at discharge, 1, 6 and 12 months

    A Serious Adverse Event (SAE) is defined as an Adverse Event which:

    • results in death
    • is life-threatening
    • results in persistent or significant disability/incapacity
    • requires in-patient hospitalization or unduly prolonged hospitalization.
    • necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure.
    • is a congenital abnormality/birth defect, a fetal distress or fetal death
    • results in malignancy

    Measured: discharge, 1, 6 and 12 months

  5. Improvement of Rutherford classification

    Improvement in Rutherford Clinical Category at 12 months, defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category at 12 months compared to baseline, that is attributable to the treated limb (in cases of bilateral disease)

    Measured: 12 months

  6. Improvement in Ankle-Brachial Index

    Improvement in Ankle-Brachial Index at 12 months, defined as an increase in the ankle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI<0.9

    Measured: 12 months

  7. Primary Patency

    Primary patency rate at 1 and 12 months, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤2.0 at the target lesion(s) with no clinically-driven reintervention within the treated segment

    Measured: 1 and 12 months

  8. Secondary patency

    Secondary patency rate at 1, 6 and 12 months, defined by duplex ultrasound peak systolic velocity ratio ≤2.0 maintained by repeat percutaneous intervention

    Measured: 1, 6 and 12 months

  9. Limb salvage rate

    Limb salvage rate, defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot

    Measured: Procedure, 1, 6 and 12 months

  10. Target Lesion Revascularisation

    Target lesion revascularization (TLR), defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.

    Measured: Procedure (day 0), 1, 6 and 12 months

Timeline

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

  1. First posted28 Jun 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2013
  4. Study completionOct 2014

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630070
Sponsor's protocol ID
FMRP-110629
Acronym
PES-BTK-70
Status last verified
Mar 2015
First submitted
18 Jun 2012
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Bosiers M, Callaert J, Keirse K, Hendriks JMH, Peeters P, Verbist J, Maene L, Beelen R, Deloose K. One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia. J Endovasc Ther. 2017 Jun;24(3):311-316. doi: 10.1177/1526602817697319. Epub 2017 Mar 9.

    PubMed 28351310

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Self-expandable drug eluting stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 5 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 12 inclusion and 16 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 9 Mar 2015. 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. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: 6 months). The study lists 2 primary outcomes in all. 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 NCT01630070, 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 9 Mar 2015.

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