Document Detail


The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year.
MedLine Citation:
PMID:  19341879     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: This phase I IDE study (STAPLE-1) evaluated the primary endpoints of safety (major device-related adverse events at 30 days) and feasibility (successful deployment of all endograft components) of the Aptus Endovascular abdominal aortic aneurysm (AAA) Repair System (Aptus Endosystems, Inc, Sunnyvale, Calif) to treat AAAs.
METHODS: A prospective, single arm Federal Drug Administration (FDA) Phase I IDE study was performed. The Aptus endograft is a three-piece modular device with a flexible unsupported main body and two fully supported limbs in a 5.3 mm outer diameter (OD) (16F) delivery system for all iliac limbs and two of three main body sizes. The largest main body (29 mm diameter) is in a 6 mm (18 F OD) delivery system. EndoStaples measuring 4 mm (length) by 3 mm (diameter) designed to provide transmural graft fixation to the adventitia are applied independent of the endograft delivery system. Inclusion criteria included a proximal aortic neck length of 12 mm and iliac landing zone of 10 mm. Secondary endpoints included freedom from endoleaks, rupture, migration, and device integrity.
RESULTS: Twenty-one (21) patients were enrolled at five centers. All patients received the Aptus Endograft and EndoStaples. Ninety-six EndoStaples (range, 2-10; median, 4) were implanted. All patients (n = 21) completed 1-month and 6-month follow-up evaluation and 14 completed 1-year follow-up. Two proximal cuffs and one limb extension were used as adjunctive endograft components at implantation. Three secondary interventions were performed in 2 patients for limb thrombosis. There were no EndoStaple-related adverse events, device integrity failures, migrations, or conversions.
CONCLUSION: These results of the STAPLE-1 trial document the acute safety and feasibility of the Aptus Endograft and EndoStaples. Early follow-up demonstrates excellent 6-month and 1-year results. A pivotal phase II trial is underway at 25 US centers.
Authors:
David H Deaton; Manish Mehta; Karthik Kasirajan; Elliot Chaikof; Mark Farber; Marc H Glickman; Richard F Neville; Ronald M Fairman
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  49     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-04-03     Completed Date:  2009-04-20     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  851-7; discussion 857-8     Citation Subset:  IM    
Affiliation:
Georgetown University Hospital, Washington, DC, USA.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Aortic Aneurysm, Abdominal / pathology,  surgery*
Blood Vessel Prosthesis*
Blood Vessel Prosthesis Implantation / adverse effects,  instrumentation*
Feasibility Studies
Female
Foreign-Body Migration / etiology,  prevention & control
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
Prosthesis Failure
Stents*
Surgical Stapling / instrumentation*
Sutures*
Time Factors
Treatment Outcome
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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