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

2014-07-24 14:24:25 | BioPortfolio

Summary

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

Description

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, 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 DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.

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

rapamycin-eluting Stent with permanent polymer, rapamycin-eluting stent with biodegradable polymer, polymer-free, rapamycin-eluting stent

Location

1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen
Germany
81675

Status

Completed

Source

Deutsches Herzzentrum Muenchen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:24:25-0400

Clinical Trials [1277 Associated Clinical Trials listed on BioPortfolio]

Rapamycin+Estradiol- vs. Rapamycin-Eluting Stents to Reduce Restenosis (ISAR-PEACE)

The purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.

Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)

The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary...

Non-Polymer-Based, Rapamycin-Eluting Stents to Prevent Restenosis

The purpose of the study is to evaluate the effectively of coating of coronary stents with two different doses of rapamycin for the prevention of coronary vessel re-blockage

Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Evaluation of Bioresorbable Rapamycin-eluting Coronary Stent System

This study is a small scale pilot research for bioresorbable rapamycin-eluting coronary stent for the first time in human body. Our goal is to access the preliminary safety and efficacy of...

PubMed Articles [3142 Associated PubMed Articles listed on BioPortfolio]

Surface-Degradable Drug-Eluting Stent with Anticoagulation, Antiproliferation, and Endothelialization Functions.

Drug-eluting stents (DES) have been widely applied for saving the life of patients with coronary artery diseases (CADs). However, conventional polymers such as polylactic acid (PLA) and poly (lactic-c...

The Pt-Cr everolimus-eluting stent with bioabsorbable polymer in the treatment of patients with acute coronary syndromes. Results from the SYNERGY ACS registry.

We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS).

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR).

Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the...

One-year clinical outcomes between biodegradable-polymer-coated biolimus-eluting stent and durable-polymer-coated drug-eluting stents in STEMI patients with multivessel coronary artery disease undergoing culprit-only or multivessel PCI.

There are limited data comparing clinical outcomes among new-generation drug-eluting stents (DES) in ST-segment elevation myocardial infarction (STEMI) patients with multivessel coronary artery diseas...

Five-year outcomes after first- and second-generation drug-eluting stent implantation in all patients undergoing percutaneous coronary intervention.

Use of the everolimus-eluting stent (EES) instead of the sirolimus-eluting stent (SES) has been shown to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) out t...

Medical and Biotech [MESH] Definitions

A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.

A multiprotein complex consisting of MTOR KINASE; MLST8 PROTEIN; rapamycin-insensitive companion of mTOR protein (RICTOR PROTEIN); and PRR5 (proline-rich protein 5). Like MTORC1, it also regulates cell growth and proliferation in response to growth factors but may not be as sensitive to nutrient availability and is insensitive to SIROLIMUS. In contrast to MTORC1, it can regulate the ACTIN CYTOSKELETON through RHO GTPASES to promote the formation of STRESS FIBERS. The mTORC2 complex also plays a critical role in AKT1 PROTEIN KINASE phosphorylation and activation.

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

An analytical technique for resolution of a chemical mixture into its component compounds. Compounds are separated on an adsorbent paper (stationary phase) by their varied degree of solubility/mobility in the eluting solvent (mobile phase).

Separation systems containing a relatively long-lived parent radionuclide which produces a short-lived daughter in its decay scheme. The daughter can be periodically extracted (milked) by means of an appropriate eluting agent.

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