Open Access Study protocol

Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial

Amine Karimi1*, Sanne W de Boer2, Daniël AF van den Heuvel2, Bram Fioole3, Dammis Vroegindeweij4, Jan MM Heyligers5, Paul NM Lohle6, Otto Elgersma7, Rudolf PT Nolthenius8, Jan Albert Vos2 and Jean-Paul PM de Vries1*

Author Affiliations

1 Department of Vascular Surgery, St. Antonius Hospital, PO box 2500, Nieuwegein, EM 3430, The Netherlands

2 Department of Interventional Radiology, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, CM 3435, The Netherlands

3 Department of Vascular Surgery, Maasstad Hospital, Maasstadweg 21, Rotterdam, DZ 3079, The Netherlands

4 Department of Interventional Radiology, Maasstad Hospital, Maasstadweg 21, Rotterdam, DZ 3079, The Netherlands

5 Department of Vascular Surgery, St. Elisabeth Hospital, Hilvarenbeekseweg 60, Tilburg, GC 5022, The Netherlands

6 Department of Interventional Radiology, St. Elisabeth Hospital, Hilvarenbeekseweg 60, Tilburg, GC 5022, The Netherlands

7 Department of Interventional Radiology, Albert Schweitzer Hospital, Albert Schweizerplaats 25, Dordrecht, AT 3318, The Netherlands

8 Department of Vascular Surgery, Albert Schweitzer Hospital, Albert Schweizerplaats 25, Dordrecht, AT 3318, The Netherlands

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Trials 2013, 14:87  doi:10.1186/1745-6215-14-87

Published: 28 March 2013

Abstract

Background

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.

Methods/Design

A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5–15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.

Discussion

The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.

Trial registration

ISRCTN47846578