Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte Coronary Stent Integrated Delivery System first-in-man trial

Diletti, Roberto; García‐García, Héctor M.; Bourantas, Christos V.; Geuns, Robert Jan van; Mieghem, Nicolas Van; Agostoni, Pierfrancesco; Muramatsu, Takashi; Farooq, Vasim; Spencer, Richard G.; Schepper, Jean De; Pomeranz, Mark; Stella, Pieter R.; Serruys, Patrick W.

doi:10.4244/eijv9i1a18

Cited by 8 publications

(2 citation statements)

References 31 publications

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“…Direct stenting has been shown to reduce contrast load, radiation exposure, procedure time and ancillary product use (guidewires, pre and post-dilatation balloons) [5][6][7][8][9][10] . These benefits have been shown to accrue with the bare metal version of the Svelte stent 11 . The low device profile also means that PCI can be readily undertaken through 5 Fr guide catheters, thereby allowing radial access even in smaller women (all procedures were via the radial approach in this study), and reducing the risk of access site complications if femoral access is used.…”

Section: Discussionmentioning

confidence: 98%

“…The Svelte drug-eluting coronary stent IDS is a proprietary lowprofile drug-eluting stent mounted on a fixed-wire delivery system (Figure 1). It is designed specifically for direct stenting and is 5 Fr guide catheter-compatible 10,11 . The stent comprises a thin-strut (81 µm) cobalt-chromium alloy L-605 stent coated with a thin (6 µm), fully bioabsorbable drug carrier (DSM, Heerlen, The Netherlands) eluting the well-studied compound sirolimus (220 µg/cm 2 ).…”

Section: Device Descriptionmentioning

confidence: 99%

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First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study

Webster

Harding²,

McClean³

et al. 2013

EuroIntervention

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Aims: The DIRECT study is a first-inhuman evaluation of the safety and efficacy of the Svelte sirolimuseluting coronary stent mounted on a fixed-wire, "all-in-one" integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobaltchromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The stent on its IDS has a very low profile, and is designed specifically to facilitate direct stenting. Methods and results: Patients with symptomatic ischaemic heart disease and a single de novo native coronary lesion suitable for percutaneous coronary intervention were prospectively enrolled at four New Zealand sites. The lesion length had to be <23 mm and the vessel reference diameter 2.5-3.5 mm. The primary safety and efficacy endpoints were target vessel failure (TVF) and angiographic in-stent late lumen loss (LLL) at six months, respectively. Twenty-nine of 30 enrolled patients completed six-month follow-up. TVF occurred in two patients (7%). The in-stent LLL was 0.22±0.27 mm. No patient had clinically-driven target lesion revascularisation. Intravascular ultrasound neointimal volume was 3.3±4.4 mm3 and volume obstruction was 2.7±4.5% at six months. Optical coherence tomography showed 98±4% strut coverage at a depth of 0.12±0.06 mm. No patient developed stent thrombosis. Conclusions: Percutaneous coronary intervention using the Svelte sirolimus-eluting coronary stent mounted on an IDS appears safe and effective in de novo coronary artery lesions, with minimal in-stent proliferation and excellent stent strut coverage at six months.

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Section: Discussionmentioning

confidence: 98%

Section: Device Descriptionmentioning

confidence: 99%

First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study

Webster

Harding²,

McClean³

et al. 2013

EuroIntervention

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Endovascular Metal Devices for the Treatment of Cerebrovascular Diseases

Zhang

et al. 2018

Advanced Materials

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Cerebrovascular disease involves various medical disorders that obstruct brain blood vessels or deteriorate cerebral circulation, resulting in ischemic or hemorrhagic stroke. Platinum coils with or without biological modification have become routine embolization devices in the cerebral aneurysm sac to reduce the risk of bleeding. Many intracranial stents, flow diverters and stent retrievers have been invented with uniquely designed structures. To accelerate the translation of these devices into clinical usage, an indepth understanding of the mechanical and material performance of these metal-based devices is critical. However, considering the more distal location and tortuous anatomic characteristics of cerebral arteries, present devices still risk failing to arrive at target lesions. Consequently, more flexible endovascular devices and novel designs are under urgent demand to overcome the deficiencies of existing devices. Herein, we discuss the pros and cons of the current structural designs when these devices are applied to the treatment of diseases ranging broadly from hemorrhages to ischemic strokes, in order to encourage further development of such kind of devices and investigation of their use in the clinic. Moreover, novel biodegradable materials and drug elution techniques, and the design, safety and efficacy of personalized devices for further clinical applications in cerebral vasculature are discussed.

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Integrated Stent Delivery System: A Next Generation of Stent Delivery and Drug-Eluting Stent

Fischell

Balmuri

Agarwal

et al. 2020

Cardiovascular Revascularization Medicine

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Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte Coronary Stent Integrated Delivery System first-in-man trial

Abstract: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

Cited by 8 publications

References 31 publications

First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study

First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study

Endovascular Metal Devices for the Treatment of Cerebrovascular Diseases

Integrated Stent Delivery System: A Next Generation of Stent Delivery and Drug-Eluting Stent

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