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Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease: The Regeneration Study.
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- Additional Information
- Source:
Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8703941 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1615-5947 (Electronic) Linking ISSN: 08905096 NLM ISO Abbreviation: Ann Vasc Surg
- Publication Information:
Publication: <2007->: Netherlands : Elsevier
Original Publication: Detroit : [Published by Expansion scientifique française for Annals of Vascular Surgery, Inc. and Association pour la promotion de la chirurgie vasculaire, Paris, c1986-
- Subject Terms:
- Abstract:
Background: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease.
Methods: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance.
Results: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6-13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak).
Conclusions: The RelayPro has a 3-4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.
(Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Publication Date:
Date Created: 20190127 Date Completed: 20190805 Latest Revision: 20190805
- Publication Date:
20231215
- Accession Number:
10.1016/j.avsg.2018.10.017
- Accession Number:
30684621
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