IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trialReportar como inadecuado




IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 15:63

First Online: 19 February 2014Received: 16 July 2013Accepted: 28 January 2014DOI: 10.1186-1745-6215-15-63

Cite this article as: Zeller, T., Baumgartner, I., Scheinert, D. et al. Trials 2014 15: 63. doi:10.1186-1745-6215-15-63

Abstract

BackgroundThe effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia CLI are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics e.g., severe calcification, chronic total occlusions, which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate -patient-centric- outcomes of functional limb preservation, mobility and quality of life QoL.

Methods-DesignIN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon IA-DEB and standard balloon angioplasty PTA in patients with Rutherford Class 4-5-6 CLI.

DiscussionThis multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss LLL and clinically driven target lesion revascularization TLR in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.

Trial registrationNCT00941733

KeywordsPeripheral vascular disease Critical limb ischemia Infrapopliteal Drug-eluting balloon AbbreviationsADEAdverse device effect

AEAdverse event

AFSAmputation-free survival

Angio-TLAngiographic target lesion

CECClinical events committee

CLICritical limb ischemia

DEBDrug-eluting balloon

DSMBData safety monitoring board

e-CRFelectronic clinical report form

IA-DEBIN.PACT Amphirion drug-eluting balloon

ITTIntention to treat

LLLLate lumen loss

MAEMajor adverse event

PTAPercutaneous transluminal angioplasty

QoLQuality of life

SADESerious adverse device effect

SAESerious adverse event

TERTarget extremity revascularization

TLTarget lesion

TLRTarget lesion revascularization

UADEUnanticipated adverse device effect

US IDEUnited States investigational device exemption

WRAWound-related artery.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-63 contains supplementary material, which is available to authorized users.

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Autor: Thomas Zeller - Iris Baumgartner - Dierk Scheinert - Marianne Brodmann - Marc Bosiers - Antonio Micari - Patrick Peeters -

Fuente: https://link.springer.com/







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