Peripheral Artery Disease
Conditions
Keywords
PAD, stenting, angioplasty
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.
Interventions
Sponsors
William Cook Europe
Provascular GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Systolic Velocity Ratio (PSVR) | 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. |
| target lesion revascularization (TLR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel revascularization (TVR) | 6, 12 and 24 months | — |
| Clinically-driven target lesion revascularization (TLR) | 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. |
| Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation | 6, 12 and 24 months | Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s). |
| Major Adverse Events (MAEs) | 6, 12 and 24 months | 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. |
| Binary restenosis | 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. |
| Walking capacity | 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. |
| Procedural success | 6, 12 and 24 months | Procedural success is defined as obtainment of \< 30% residual stenosis on angiography by visual estimate. |
| Sustained clinical improvement | 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). |
| All cause death | 6, 12 and 24 months | — |
Countries
Belgium, Germany
Outcome results
None listed