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Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography

2014-08-27 03:14:50 | BioPortfolio

Summary

The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stents (ISAR G2, Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.

Description

The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Heart Disease

Intervention

Nobori® or ISAR G2 (Biodegradable polymer limus-eluting stents), Xience-V® (Permanent polymer limus-eluting stent)

Location

Deutsches Herzzentrum Muenchen
Munich
Germany
80636

Status

Recruiting

Source

Deutsches Herzzentrum Muenchen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:50-0400

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Medical and Biotech [MESH] Definitions

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Devices that provide support for tubular structures that are being anastomosed or for body cavities during skin grafting.

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