title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN47846578.
authors.affiliation: Department of Vascular Surgery, St. Antonius Hospital, PO box 2500, Nieuwegein, EM 3430, The Netherlands. a.karimi@antoniusziekenhuis.nl
authors.forename: Amine
authors.initials: A
authors.lastname: Karimi
authors.forename: Sanne W
authors.initials: SW
authors.lastname: de Boer
authors.forename: Daniël A F
authors.initials: DA
authors.lastname: van den Heuvel
authors.forename: Bram
authors.initials: B
authors.lastname: Fioole
authors.forename: Dammis
authors.initials: D
authors.lastname: Vroegindeweij
authors.forename: Jan M M
authors.initials: JM
authors.lastname: Heyligers
authors.forename: Paul N M
authors.initials: PN
authors.lastname: Lohle
authors.forename: Otto
authors.initials: O
authors.lastname: Elgersma
authors.forename: Rudolf P T
authors.initials: RP
authors.lastname: Nolthenius
authors.forename: Jan Albert
authors.initials: JA
authors.lastname: Vos
authors.forename: Jean-Paul P M
authors.initials: JP
authors.lastname: de Vries
mesh_terms: D000497:Alloys; D000671:Amputation, Surgical; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D004867:Equipment Design; D004868:Equipment Failure; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006439:Hemodynamics; D006801:Humans; D006965:Hyperplasia; D023821:Limb Salvage; D058426:Neointima; D009426:Netherlands; D017239:Paclitaxel / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D012107:Research Design; D012116:Resins, Plant; D016037:Single-Blind Method; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D062666:Vascular Access Devices
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D012116:Resins, Plant; C013616:nitinol; C003934:shellac; D017239:Paclitaxel
references.citation: Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5
references.pmid: 19859954
references.citation: Indian Heart J. 2006 Jan-Feb;58(1):57-60
references.pmid: 18984934
references.citation: Minerva Cardioangiol. 2011 Oct;59(5):431-45
references.pmid: 21983304
references.citation: Asian Cardiovasc Thorac Ann. 2011 Dec;19(6):407-10
references.pmid: 22160410
references.citation: Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1223-6
references.pmid: 22419657
references.citation: Circulation. 2007 May 29;115(21):2745-9
references.pmid: 17502568
references.citation: J Vasc Surg. 2007 Jan;45 Suppl S:S5-67
references.pmid: 17223489
references.citation: N Engl J Med. 2008 Feb 14;358(7):689-99
references.pmid: 18272892
references.citation: J Vasc Surg. 2009 Feb;49(2):371-7
references.pmid: 19028064
references.citation: Catheter Cardiovasc Interv. 2010 Sep 1;76(3):395-403
references.pmid: 20839356
references.citation: Eur J Vasc Endovasc Surg. 2008 Nov;36(5):582-91
references.pmid: 18804390
references.citation: Eur J Vasc Endovasc Surg. 2008 Oct;36(4):409-19
references.pmid: 18692415
references.citation: Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S43-59
references.pmid: 22172473
references.citation: J Interv Cardiol. 2011 Dec;24(6):518-28
references.pmid: 21917013
references.citation: Circulation. 2008 Sep 23;118(13):1358-65
references.pmid: 18779447