دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Nasser F; Santa Marcelina Hospital, São Paulo, Brazil., Kambara A; Dante Pazzanese Institute of Cardiology, São Paulo, Brazil., Abath C; Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil., Cavalcanti D; Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil., Barros I; Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil., Pires N; Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil., Rivera M; Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil., Neser A; Santa Marcelina Hospital, São Paulo, Brazil., Ingrund J; Santa Marcelina Hospital, São Paulo, Brazil., Burihan M; Santa Marcelina Hospital, São Paulo, Brazil., Silveira P; Baía Sul Medical Center, CORIS, Florianópolis, Brazil., Galego G; Baía Sul Medical Center, CORIS, Florianópolis, Brazil., Bortoluzzi C; Baía Sul Medical Center, CORIS, Florianópolis, Brazil., Franklin R; Baía Sul Medical Center, CORIS, Florianópolis, Brazil., Bosiers M; Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium - office@fmrp.be., Deloose K; Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium., Razuk A; Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil., Caffaro R; Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil., Karakhanian WK; Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil., Park J; Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil., Lopes C; Hospital Felício Rocho, Belo Horizonte, Brazil., Pinto D; Hospital Felício Rocho, Belo Horizonte, Brazil., Bez L; Hospital Felício Rocho, Belo Horizonte, Brazil., Lopes R; Hospital Felício Rocho, Belo Horizonte, Brazil., Mourão A; Hospital Felício Rocho, Belo Horizonte, Brazil., Kleinsorge G; Hospital Felício Rocho, Belo Horizonte, Brazil. |
| المصدر: | The Journal of cardiovascular surgery [J Cardiovasc Surg (Torino)] 2017 Jun; Vol. 58 (3), pp. 409-415. Date of Electronic Publication: 2015 Mar 03. |
| نوع المنشور: | Clinical Trial; Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Edizioni Minerva Medica Country of Publication: Italy NLM ID: 0066127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1827-191X (Electronic) Linking ISSN: 00219509 NLM ISO Abbreviation: J Cardiovasc Surg (Torino) Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Torino : Edizioni Minerva Medica |
| مواضيع طبية MeSH: | Alloys* , Femoral Artery*/diagnostic imaging , Femoral Artery*/physiopathology , Stents*, Endovascular Procedures/*instrumentation , Peripheral Arterial Disease/*therapy, Adult ; Aged ; Aged, 80 and over ; Angiography ; Ankle Brachial Index ; Brazil ; Disease-Free Survival ; Endovascular Procedures/adverse effects ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/physiopathology ; Prospective Studies ; Prosthesis Design ; Time Factors ; Treatment Outcome ; Ultrasonography, Doppler, Duplex ; Vascular Patency |
| مستخلص: | 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. Results: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%). Conclusions: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions. |
| المشرفين على المادة: | 0 (Alloys) 2EWL73IJ7F (nitinol) |
| تواريخ الأحداث: | Date Created: 20150304 Date Completed: 20170410 Latest Revision: 20170410 |
| رمز التحديث: | 20231215 |
| DOI: | 10.23736/S0021-9509.16.08471-8 |
| PMID: | 25731858 |
| قاعدة البيانات: | MEDLINE |
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