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

This study has been completed.
Sponsor:
Collaborator:
William Cook Europe
Information provided by (Responsible Party):
Provascular GmbH
ClinicalTrials.gov Identifier:
NCT01728441
First received: November 13, 2012
Last updated: May 19, 2014
Last verified: May 2014

November 13, 2012
May 19, 2014
October 2012
May 2014   (final data collection date for primary outcome measure)
  • Peak Systolic Velocity Ratio (PSVR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • target lesion revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • PSVR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • TLR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
Complete list of historical versions of study NCT01728441 on ClinicalTrials.gov Archive Site
  • Major Adverse Events (MAEs) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

    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.
  • All cause death [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization (TVR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Clinically-driven target lesion revascularization (TLR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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.
  • Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).
  • Sustained clinical improvement [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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).
  • Binary restenosis [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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.
  • Walking capacity [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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.
  • Procedural success [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.
  • Major Adverse Events (MAEs) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

    MAE is defined as:

    • Death within 30 days of the index procedure or within 30 days of a TLR
    • Clinically-driven TLR, or
    • Major target limb amputation.
  • All cause death [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization (TVR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Clinically-driven target lesion revascularization (TLR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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 PAD following the initial procedure.
  • Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).
  • Sustained clinical improvement [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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 TLR.
  • Binary restenosis [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Binary restenosis (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.
  • Walking capacity [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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.
  • Procedural success [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.
Not Provided
Not Provided
 
Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
  • Device: Paclitaxel Eluting Stent
    Other Name: Zilver PTX stent
  • Device: Paclitaxel Eluting Balloon
  • Experimental: Paclitaxel Eluting Stent
    Patients 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.
    Intervention: Device: Paclitaxel Eluting Stent
  • Active Comparator: Paclitaxel Eluting Balloon
    For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.
    Intervention: Device: Paclitaxel Eluting Balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

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.
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Belgium
 
NCT01728441
Prov 01-2012, U1111-1136-8610
Yes
Provascular GmbH
Provascular GmbH
William Cook Europe
Principal Investigator: Dierk Scheinert, MD Park Hospital Leipzig
Provascular GmbH
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP