- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728441
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bonheiden, Belgium, 2820
- Imelda Hospital
-
Dendermonde, Belgium, 9200
- AZ Sint-Blasius Department of Vascular Surgery
-
-
-
-
-
Bad Krozingen, Germany, 79189
- Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie
-
Hamburg, Germany, 22527
- Angiologikum Hamburg Centre for Interventional Vascular Medicine
-
Leipzig, Germany, 04289
- Park-Krankenhaus Leipzig
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Other Names:
|
Active Comparator: Paclitaxel Eluting Balloon
For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 12 months
|
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)
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Events (MAEs)
Time Frame: 6, 12 and 24 months
|
MAE is defined as:
|
6, 12 and 24 months
|
All cause death
Time Frame: 6, 12 and 24 months
|
6, 12 and 24 months
|
|
Target vessel revascularization (TVR)
Time Frame: 6, 12 and 24 months
|
6, 12 and 24 months
|
|
Clinically-driven target lesion revascularization (TLR)
Time Frame: 6, 12 and 24 months
|
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.
|
6, 12 and 24 months
|
Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation
Time Frame: 6, 12 and 24 months
|
Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).
|
6, 12 and 24 months
|
Sustained clinical improvement
Time Frame: 6, 12 and 24 months
|
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).
|
6, 12 and 24 months
|
Binary restenosis
Time Frame: 6, 12 and 24 months
|
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.
|
6, 12 and 24 months
|
Walking capacity
Time Frame: 6, 12 and 24 months
|
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.
|
6, 12 and 24 months
|
Procedural success
Time Frame: 6, 12 and 24 months
|
Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.
|
6, 12 and 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dierk Scheinert, MD, Park Hospital Leipzig
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- Prov 01-2012
- U1111-1136-8610 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Peripheral Artery Occlusive DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Boston Scientific CorporationCompletedAtherosclerosis | Peripheral Artery Disease | Plaque, Atherosclerotic | Artery Diseases, Peripheral | Occlusive Arterial DiseaseUnited States, Belgium, Canada, Japan, Austria, New Zealand
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
Clinical Trials on Paclitaxel Eluting Stent
-
Cook Group IncorporatedCompletedPeripheral Arterial Disease (PAD)Germany, New Zealand
-
Heart Centre RotenburgB. Braun Medical SACompletedDiabetes Mellitus | Coronary StenosisMalaysia
-
Aarhus University Hospital SkejbyMedtronic Cardiovascular; Biosensors InternationalCompletedCoronary Artery Disease | Angina PectorisDenmark
-
Abbott Medical DevicesCompletedMyocardial Ischemia | Coronary Artery Disease | Stent Thrombosis | Vascular Disease | Coronary Artery Stenosis | Stents | Total Coronary Occlusion | Coronary Artery RestenosisUnited States
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary RestenosisNetherlands, Spain, Denmark, Germany, France, Austria, Belgium, India, Italy, New Zealand, Poland, South Africa, Switzerland
-
Abbott Medical DevicesCompletedCoronary Artery DiseaseUnited States
-
Fondazione Evidence per Attività e Ricerche Cardiovascolari...Unknown
-
Cordis CorporationConor MedsystemsTerminatedCoronary AtherosclerosisBrazil, New Zealand
-
Cordis CorporationConor MedsystemsCompletedCoronary DiseaseUnited States
-
Laval UniversityBoston Scientific CorporationCompletedCoronary Artery Bypass GraftingCanada