BeGraft Peripheral PMCF Study: 12-month results.
Autor: | Deloose K; A.Z. Sint-Blasius, Dendermonde, Belgium - koen.deloose@telenet.be., Bosiers M; A.Z. Sint-Blasius, Dendermonde, Belgium., Callaert J; A.Z. Sint-Blasius, Dendermonde, Belgium., Peeters P; Imelda Hospital, Bonheiden, Belgium., Verbist J; Imelda Hospital, Bonheiden, Belgium., van den Eynde W; Imelda Hospital, Bonheiden, Belgium., Maene L; OLV Hospital, Aalst, Belgium., Beelen R; OLV Hospital, Aalst, Belgium., Keirse K; Heilig Hart Hospital, Tienen, Belgium. |
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Jazyk: | angličtina |
Zdroj: | The Journal of cardiovascular surgery [J Cardiovasc Surg (Torino)] 2019 Apr; Vol. 60 (2), pp. 230-236. Date of Electronic Publication: 2017 May 26. |
DOI: | 10.23736/S0021-9509.17.09916-5 |
Abstrakt: | Background: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months. Methods: Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%. Results: Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%. Conclusions: These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future. |
Databáze: | MEDLINE |
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