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Peripheral Artery DiseaseNCT01728441

Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery

A study testing Paclitaxel Eluting Stent and Paclitaxel Eluting Balloon in people with Peripheral Artery Disease, run by Provascular GmbH 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
Search all trials

Trial summary

Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Paclitaxel Eluting Stent and Paclitaxel Eluting Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
5 sitesin 2 countries
Study dates
Oct 2012to May 2014
Phase
Interventional
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

  • Subject age ≥ 18
  • Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
  • Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
  • Rutherford category 2-5.
  • Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
  • Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
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  • A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis might, at the decision of the investigator, be considered as 2 lesions).
  • Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment.
  • Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
  • A guidewire has successfully traversed the target treatment segment.

Who cannot join

  • Clinical exclusion criteria
  • Inability to obtain informed consent.
  • Life expectancy < 12 months.
  • Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment).
  • Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure.
  • Any evidence of hemodynamic instability prior to procedure/randomization.
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  • Coagulopathy or clotting disorders.
  • Present or suspected systemic infection or osteomyelitis affecting target limb.
  • Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
  • Hypersensitivity to nitinol and/or paclitaxel.
  • Enrollment into another study.
  • Intervention of the target lesion less than 90 days prior of the study procedure.
  • Anatomic Exclusion Criteria:
  • Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures).
  • Total occlusion uncrossable by a conventional guidewire.
  • Acute occlusive intraluminal thrombosis of the proposed lesion site.
  • Evidence of an aneurysm at the target lesion site.
  • Perforation in the target vessel as evidenced by the extravasation of contrast.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany3 sites

  • Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie

    Bad Krozingen, 79189

  • Angiologikum Hamburg Centre for Interventional Vascular Medicine

    Hamburg, 22527

  • Park-Krankenhaus Leipzig

    Leipzig, 04289

Other trials in Germany

Belgium2 sites

  • Imelda Hospital

    Bonheiden, 2820

  • AZ Sint-Blasius Department of Vascular Surgery

    Dendermonde, 9200

Other trials in Belgium

About this study

Official title: REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery

Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.

Read the detailed description

The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral artery disease of the femoropopliteal artery.

Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be completed within approximately six months of initiating the study.

One group (DES or DEB) will be considered to yield significantly better results of the primary patency rate than the other group at 12 months follow up.

Being tested
Paclitaxel Eluting Stent, Paclitaxel Eluting Balloon
Keywords
PAD, stenting, angioplasty
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • Paclitaxel Eluting StentDevice

    Also called Zilver PTX stent

  • Paclitaxel Eluting BalloonDevice

Study groups in NCT01728441
Study groupRoleWhat they receive
Paclitaxel Eluting StentExperimentalPatients randomized to treatment with paclitaxel eluting stent will receive the Zilver® PTX® stent.Primary stenting should be performed covering the full lesion. Post-dilatation is at the investigator's discretion.
Receives: Device: Paclitaxel Eluting Stent
Paclitaxel Eluting BalloonActive comparatorFor patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.
Receives: Device: Paclitaxel Eluting Balloon

What is being measured

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

  1. Peak Systolic Velocity Ratio (PSVR)

    The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis.

    Measured: 12 months

  2. target lesion revascularization (TLR)

    The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis.

    Measured: 12 months

Secondary outcomes (9)

  1. Major Adverse Events (MAEs)

    MAE is defined as:

    • Death within 30 days of the index procedure or within 30 days of a target lesion revascularization (TLR)
    • Clinically-driven TLR, or
    • Major target limb amputation.

    Measured: 6, 12 and 24 months

  2. All cause death

    Measured: 6, 12 and 24 months

  3. Target vessel revascularization (TVR)

    Measured: 6, 12 and 24 months

  4. Clinically-driven target lesion revascularization (TLR)

    Clinically-driven TLR is defined as a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral artery disease (PAD) following the initial procedure.

    Measured: 6, 12 and 24 months

  5. Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation

    Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).

    Measured: 6, 12 and 24 months

  6. Sustained clinical improvement

    Sustained clinical improvement is defined as an improvement in the Rutherford category of one class compared to baseline in surviving patients who are free from major target limb amputation and free from target lesion revascularization (TLR).

    Measured: 6, 12 and 24 months

  7. Binary restenosis

    Binary restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)of the target lesion at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.

    Measured: 6, 12 and 24 months

  8. Walking capacity

    Walking capacity assessment by walking impairment questionnaire (WIQ) at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.

    Measured: 6, 12 and 24 months

  9. Procedural success

    Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.

    Measured: 6, 12 and 24 months

Timeline

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

  1. First posted19 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2014
  4. Study completionMay 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728441
Sponsor's protocol ID
Prov 01-2012
Other IDs
U1111-1136-8610
Status last verified
May 2014
First submitted
13 Nov 2012
Last updated
20 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Bausback Y, Wittig T, Schmidt A, Zeller T, Bosiers M, Peeters P, Brucks S, Lottes AE, Scheinert D, Steiner S. Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease. J Am Coll Cardiol. 2019 Feb 19;73(6):667-679. doi: 10.1016/j.jacc.2018.11.039.

    PubMed 30765033

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel Eluting Stent and Paclitaxel Eluting Balloon in people with Peripheral Artery Disease, run by Provascular GmbH 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 10 inclusion and 18 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 20 May 2014. 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 Germany, 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.

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?

Peak Systolic Velocity Ratio (PSVR) (time frame: 12 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 NCT01728441, 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 20 May 2014.

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