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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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PubMed Articles [2112 Associated PubMed Articles listed on BioPortfolio]

A propensity score matched comparison of biodegradable polymer versus second-generation durable polymer drug-eluting stents in a real-world population.

The safety and efficacy of BP-DES compared to second-generation DP-DES remain unclear in the real-world setting. We compared the clinical outcomes of biodegradable polymer drug-eluting stents (BP-DES)...

Temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents.

Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Patholog...

Progress in Research Drug Eluting Stents Drug-looding and Drug Release Kinetics.

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Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6‑month vs. 12‑month dual-antiplatelet therapy (DAPT).

Diabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (D...

Comparison Between Two Biodegradable Polymer-Based Sirolimus-Eluting Stents with Differing Drug Elution and Polymer Absorption Kinetics: Two-Year Clinical Outcomes of the PANDA III Trial.

In PANDA III trial, the novel poly-lactide-co-glycolide polymer-based BuMA sirolimus-eluting stent (SES) was non-inferior to the polylactide polymer-based Excel SES for the primary endpoint of 1-year ...

Medical and Biotech [MESH] Definitions

Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.

Strongly cationic polymer that binds to certain proteins; used as a marker in immunology, to precipitate and purify enzymes and lipids. Synonyms: aziridine polymer; Epamine; Epomine; ethylenimine polymer; Montrek; PEI; Polymin(e).

A polymer obtained by reacting polyacrylic acid with a special anion-leachable glass (alumino-silicate). The resulting cement is more durable and tougher than others in that the materials comprising the polymer backbone do not leach out.

A polyester used for absorbable sutures & surgical mesh, especially in ophthalmic surgery. 2-Hydroxy-propanoic acid polymer with polymerized hydroxyacetic acid, which forms 3,6-dimethyl-1,4-dioxane-dione polymer with 1,4-dioxane-2,5-dione copolymer of molecular weight about 80,000 daltons.

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

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