Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
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Multicenter Study Clinical Trial
Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease.
To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions. ⋯ MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.
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Multicenter Study Comparative Study
Effects of Anesthesia Type on Perioperative Outcome After Endovascular Aneurysm Repair.
To examine outcomes of endovascular aortic aneurysm repair (EVAR) using general, regional, or local anesthesia. ⋯ Type of anesthesia used during EVAR has no influence on perioperative mortality and morbidity. The use of local or regional anesthesia during EVAR appeared to be beneficial concerning procedure time, ICU admission, and postoperative hospital stay.
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Multicenter Study Observational Study
Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry.
To present the results of rheolytic pharmacomechanical thrombectomy (PMT) for the management of acute limb ischemia (ALI) as reported in the PEARL Registry (PEripheral Use of AngioJet Rheolytic Thrombectomy with a variety of catheter Lengths). ⋯ The results support the use of PMT as a first-line treatment for ALI, providing a rapid reperfusion to the extremity, reduced procedure time, and an acceptable risk profile without compromising limb salvage.
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Randomized Controlled Trial Multicenter Study
A review of antithrombotic therapy and the rationale and design of the randomized edoxaban in patients with peripheral artery disease (ePAD) trial adding edoxaban or clopidogrel to aspirin after femoropopliteal endovascular intervention.
Compared with the coronary setting, knowledge about antithrombotic therapies after endovascular treatment (EVT) is inadequate in patients with peripheral artery disease (PAD). Based on a review of trials and guidelines, which is summarized in this article, there is scant evidence that antithrombotic drugs improve outcome after peripheral EVT. To address this knowledge gap, the randomized, open-label, multinational edoxaban in patients with Peripheral Artery Disease (ePAD) study (ClinicalTrials.gov identifier NCT01802775) was designed to explore the safety and efficacy of a combined regimen of antiplatelet therapy with clopidogrel and anticoagulation with edoxaban, a selective and direct factor Xa inhibitor, both combined with aspirin. ⋯ The primary safety endpoint is major or clinically relevant nonmajor bleeding; the primary efficacy endpoint is restenosis or reocclusion at the treated segment(s) measured at 1, 3, and 6 months using duplex ultrasound scanning. All outcomes will be assessed and adjudicated centrally in a masked fashion. The ePAD study is the first of its kind to investigate a combined regimen of antiplatelet therapy and anticoagulation through factor Xa inhibition with edoxaban.
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Multicenter Study
When not to implant the multilayer flow modulator: lessons learned from application outside the indications for use in patients with thoracoabdominal pathologies.
To scrutinize registry data on thoracoabdominal repairs performed using the Multilayer Flow Modulator (MFM) outside the indications for use (IFU) and analyze the adverse outcomes. ⋯ There are clinical scenarios in which the MFM does not perform well. The MFM is not a solution for patients living on borrowed time and should not be used indiscriminately in patients in whom other modalities of aortic repair are not feasible. Its use must adhere to the IFU, and robust clinical data are required before constructing a randomized controlled trial.