Six-month clinical and angiographic results of the STENTYS® self-apposing stent in bifurcation lesions.

Aims: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions.

Methods And Results: The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.

Background: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.

Methods: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone.

First-in-man (FIM) study of the Stentys bifurcation stent--30 days results.

Aims: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent.

Methods And Results: The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years.

A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial.

Background: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.

Methods: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) versus the TAXUS Paclitaxel Eluting Coronary Stent System (TAXUS(R) PECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different epicardial vessels. Three hundred patients with evidence of myocardial ischaemia were allocated to stent implantation with an everolimus-eluting stent (n=223) or a paclitaxel-eluting stent (n=77).

Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material.

The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels: a European Registry (FASTER) was designed to demonstrate that (1) the Proxis embolic protection system can control anterograde flow and reverse blood flow in native coronary arteries and saphenous vein grafts; and (2) this system can capture embolic debris. Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease, but is associated with the risk of major adverse cardiac events. This prospective, nonrandomized, multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection (Proxis system).