NCT01728441

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

November 13, 2012

Last Update Submit

May 19, 2014

Conditions

Peripheral Artery Disease

Keywords

PADstentingangioplasty

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months

  • 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.

    12 months

Secondary Outcomes (9)

  • Major Adverse Events (MAEs)

    6, 12 and 24 months

  • All cause death

    6, 12 and 24 months

  • Target vessel revascularization (TVR)

    6, 12 and 24 months

  • Clinically-driven target lesion revascularization (TLR)

    6, 12 and 24 months

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

    6, 12 and 24 months

  • +4 more secondary outcomes

Study Arms (2)

Paclitaxel Eluting Stent

EXPERIMENTAL

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.

Device: Paclitaxel Eluting Stent

Paclitaxel Eluting Balloon

ACTIVE COMPARATOR

For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.

Device: Paclitaxel Eluting Balloon

Interventions

Paclitaxel Eluting StentDEVICE
Also known as: Zilver PTX stent
Paclitaxel Eluting Stent
Paclitaxel Eluting BalloonDEVICE
Paclitaxel Eluting Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius Department of Vascular Surgery

Dendermonde, 9200, Belgium

Location

Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie

Bad Krozingen, 79189, Germany

Location

Angiologikum Hamburg Centre for Interventional Vascular Medicine

Hamburg, 22527, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, 04289, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30765033DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Dierk Scheinert, MD

    Park Hospital Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 19, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

DE(3)BE(2)