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

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728441
• Other study ID #: Prov 01-2012
• Secondary ID: U1111-1136-8610
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: May 19, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Provascular GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Paclitaxel Eluting Stent

• Paclitaxel Eluting Balloon

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius Department of Vascular Surgery	Dendermonde
Germany	Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie	Bad Krozingen
Germany	Angiologikum Hamburg Centre for Interventional Vascular Medicine	Hamburg
Germany	Park-Krankenhaus Leipzig	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
Provascular GmbH	William Cook Europe

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	6, 12 and 24 months	No
Secondary	All cause death		6, 12 and 24 months	No
Secondary	Target vessel revascularization (TVR)		6, 12 and 24 months	No
Secondary	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.	6, 12 and 24 months	No
Secondary	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).	6, 12 and 24 months	No
Secondary	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).	6, 12 and 24 months	No
Secondary	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.	6, 12 and 24 months	No
Secondary	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.	6, 12 and 24 months	No
Secondary	Procedural success	Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.	6, 12 and 24 months	No