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Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

2014-08-27 03:15:55 | BioPortfolio

Summary

The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).

Description

Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs − rapamycin, everolimus and biolimus − are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.

Study Design

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

Conditions

Coronary Heart Disease

Intervention

Nobori® (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: 2014-08-27T03:15:55-0400

Clinical Trials [609 Associated Clinical Trials listed on BioPortfolio]

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

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-elu...

A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI

This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and unc...

Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3)

The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

A Randomised Multi-Center Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Cor

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant red...

Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable pol...

PubMed Articles [2672 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)...

Very Late Pathological Responses to Cobalt-Chromium Everolimus-Eluting, Stainless Steel Sirolimus-Eluting, and Cobalt-Chromium Bare Metal Stents in Humans.

The "very late" clinical outcomes for durable polymer drug-eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long-term vascular compat...

Endothelial Barrier Protein Expression in Biodegradable Polymer Sirolimus-Eluting Versus Durable Polymer Everolimus-Eluting Metallic Stents.

This study sought to investigate endothelial coverage and barrier protein expression following stent implantation.

Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions.

Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus elut...

Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up.

The aim of this study was to compare neointima proliferation in three drug-eluting stents (DES) produced by the same company (Balton, Poland) which are covered with a biodegradable polymer and elute s...

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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