Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial
J Cardiovasc Surg (Torino)
; 58(3): 409-415, 2017. tab, graf
Article
in En
| SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1063653
Responsible library:
BR79.1
Localization: BR79.1
ABSTRACT
BACKGROUND:
The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA).METHODS:
From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months.Key words
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Collection:
06-national
/
BR
Database:
SES-SP
/
SESSP-IDPCPROD
Main subject:
Vascular Patency
/
Angiography
/
Stents
/
Endovascular Procedures
Type of study:
Clinical_trials
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
J Cardiovasc Surg (Torino)
Year:
2017
Document type:
Article