Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair.

2018

Purpose: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double “D-shaped” stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. Methods: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, an…

Multidisciplinary approach to treat ruptured abdominal aortic aneurysm into the vena cava.

2020

Editor's Choice – Occurrence and Classification of Proximal Type I Endoleaks After EndoVascular Aneurysm Sealing Using the Nellix™ Device

2017

Objective/Background Proximal type I endoleaks are associated with abdominal aortic aneurysm (AAA) growth and rupture and necessitate repair. The Nellix™ EndoVascular Aneurysm Sealing (EVAS) system is a unique approach to AAA repair, where the appearance and treatment of endoleaks is also different. This study aimed to analyse and categorise proximal endoleaks in an EVAS treated cohort. Methods All patients, treated from February 2013 to December 2015, in 15 experienced EVAS centres, presenting with proximal endoleak were included. Computed tomography scans were analysed by a core laboratory. A consensus meeting was organised to discuss and qualify each case for selection, technical aspects…

Chimney Technique with Nellix EndoVascular Aneurysm Sealing System in a Patient with Single Kidney and Juxtarenal Abdominal Aortic Aneurysm

2016

AbstractWe present a saccular asymptomatic juxtarenal abdominal aortic aneurysm in a 70-year-old male with a very short left renal artery supplying the only kidney. The case was successfully treated with the Nellix EndoVascular Aneurysm Sealing system combined with a chimney technique.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass

2019

The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composi…

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

2021

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-d…

The DETOUR procedure: no more need for conventional bypass surgery?

2018

Background Long segment occlusive disease in the superficial femoral artery remains a treatment challenge despite advances in open surgical and endovascular approaches. We report initial clinical results of an entirely new procedure to perform percutaneous femoro-popliteal bypass using the DETOUR System. First-in-human patients were performed in New Zealand from December 2013 to June 2014. After modifications to the technique and devices had significantly refined the procedure, the Detour I Trial commenced. Methods Review of initial results in the first five patients treated at a single site enrolled in IRB-approved, prospective clinical study using the DETOUR System. All patients signed in…

sj-docx-1-jet-10.1177_15266028211034862 – Supplemental material for Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

2021

Supplemental material, sj-docx-1-jet-10.1177_15266028211034862 for Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System by Grzegorz Halena, Dainis K. Krievins, Dierk Scheinert, Janis Savlovskis, Piotr Szopiński, Albrecht Krämer, Kenneth Ouriel, Andrej Schmidt, Michal Zdunek and Sean P. Lyden in Journal of Endovascular Therapy

sj-docx-1-jet-10.1177_15266028211034862 – Supplemental material for Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

2021

Supplemental material, sj-docx-1-jet-10.1177_15266028211034862 for Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System by Grzegorz Halena, Dainis K. Krievins, Dierk Scheinert, Janis Savlovskis, Piotr Szopiński, Albrecht Krämer, Kenneth Ouriel, Andrej Schmidt, Michal Zdunek and Sean P. Lyden in Journal of Endovascular Therapy