First-in-man assessment of the InSeal VCD, a novel closuredevice for large puncture accesses

To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large punctureholes following percutaneous structural interventions.Methods and results: Prospective, non-randomised, single-arm, single-centre study with a series ofpatients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheteraortic valve implantation in whom the InSeal VCD was used to close the access site. These patients werefollowed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primaryendpoint was the occurrence of major vascular complications at the puncture site. From a total of ninepatients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes wereachieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascularcomplications were observed during the follow-up period. Average ankle-brachial index pre-interventionand at one-month follow-up were 0.85 and 0.82, respectively.Conclusions: The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis afterusage of higher profile endovascular devices in this study. These results translated into no clinical complicationsup to one-year clinical follow-up.

Randomized, Double-Blind, Multicenter Study of the Polymer-Based 17-b Estradiol-Eluting Stent for Treatment of Native Coronary Artery Lesions: Six-Month Results of the ETHOS I Trial

Objectives: The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-b estradiol-eluting RStent TM versus uncoated control stents for the treatment of patients with single de novo native coronary lesions. Background: Estrogens were reported to inhibit neointimal proliferation and to accelerate endothelial regeneration after coronary angioplasty and thus could be an ideal compound to deliver on a stent for the purpose of reducing in-stent restenosis. Methods: Ninety-five patients were randomized to receive a slowrelease (n = 32) or the moderate release (n = 31) formulations or the bare metal stent (n = 32). The primary end point was the 6-month percent in-stent volume obstruction by intravascular ultrasound (IVUS). Results: Diabetes was present in 29.5% of patients; the mean reference vessel diameter was 2.90 mm; and the mean lesion length was 13.5 mm. Primary endpoint, 6-month percent in-stent volume obstruction by IVUS, did not differ significantly between the 3 groups (31% 6 14%, 33% 6 11%, and 31% 6 14%, P = 0.83). Secondary endpoints also did not differ significantly between the groups including 6-month rates of in-lesion binary angiographic restenosis (13.3%, 14.3%, and 12.5%, P = 0.98), in-stent late loss (0.82 6 0.49 mm, 0.86 6 0.53 mm, and 0.84 6 0.46 mm, P = 0.97), target lesion revascularization (12.5%, 6.9%, and 6.5%, P = 0.64), and major adverse cardiac events (18.8%, 10.3%, and 6.5%, P = 0.31). Conclusions: In this first-in-man randomized trial, the 17-b estradiol-eluting R-StentTM, in either slowor moderate-release formulations, was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls.