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

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Paclitaxel Eluting Stent
Paclitaxel Eluting Balloon
Sponsored by
Provascular GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring PAD, stenting, angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imelda Hospital
  • AZ Sint-Blasius Department of Vascular Surgery
  • Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie
  • Angiologikum Hamburg Centre for Interventional Vascular Medicine
  • Park-Krankenhaus Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel Eluting Stent

Paclitaxel Eluting Balloon

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
All cause death
Target vessel revascularization (TVR)
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.
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).
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).
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.
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.
Procedural success
Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.

Full Information

First Posted
November 13, 2012
Last Updated
May 19, 2014
Sponsor
Provascular GmbH
Collaborators
William Cook Europe
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1. Study Identification

Unique Protocol Identification Number
NCT01728441
Brief Title
Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provascular GmbH
Collaborators
William Cook Europe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
PAD, stenting, angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel Eluting Stent
Arm Type
Experimental
Arm Description
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.
Arm Title
Paclitaxel Eluting Balloon
Arm Type
Active Comparator
Arm Description
For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.
Intervention Type
Device
Intervention Name(s)
Paclitaxel Eluting Stent
Other Intervention Name(s)
Zilver PTX stent
Intervention Type
Device
Intervention Name(s)
Paclitaxel Eluting Balloon
Primary Outcome Measure Information:
Title
Peak Systolic Velocity Ratio (PSVR)
Description
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.
Time Frame
12 months
Title
target lesion revascularization (TLR)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major Adverse Events (MAEs)
Description
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.
Time Frame
6, 12 and 24 months
Title
All cause death
Time Frame
6, 12 and 24 months
Title
Target vessel revascularization (TVR)
Time Frame
6, 12 and 24 months
Title
Clinically-driven target lesion revascularization (TLR)
Description
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.
Time Frame
6, 12 and 24 months
Title
Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation
Description
Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).
Time Frame
6, 12 and 24 months
Title
Sustained clinical improvement
Description
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).
Time Frame
6, 12 and 24 months
Title
Binary restenosis
Description
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.
Time Frame
6, 12 and 24 months
Title
Walking capacity
Description
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.
Time Frame
6, 12 and 24 months
Title
Procedural success
Description
Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, MD
Organizational Affiliation
Park Hospital Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Sint-Blasius Department of Vascular Surgery
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Angiologikum Hamburg Centre for Interventional Vascular Medicine
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Park-Krankenhaus Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30765033
Citation
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.
Results Reference
derived

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

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