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The Valentines Trial

2014-08-27 03:16:00 | BioPortfolio

Summary

The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late occurrences will be assessed.

In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.

A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Instent Restenosis

Intervention

Paclitaxel

Location

Heart Center Munich at the Isar
Munich
Germany

Status

Active, not recruiting

Source

Eurocor GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:00-0400

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PubMed Articles [297 Associated PubMed Articles listed on BioPortfolio]

Incidence and Predictors of reCurrent Restenosis After Drug-coated Balloon Angioplasty for Restenosis of a drUg-eluting Stent: The ICARUS Cooperation.

The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and ...

Therapeutic Options for In-Stent Restenosis.

In-stent restenosis (ISR) is a complex disease process that became apparent shortly after the introduction of stents into clinical practice. This review seeks to define in-stent restenosis (ISR) as we...

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Antibody-nanoparticle conjugate constructed with trastuzumab and nanoparticle albumin-bound paclitaxel for targeted therapy of human epidermal growth factor receptor 2-positive gastric cancer.

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Recurrent narrowing or constriction of a coronary artery following surgical procedures performed to alleviate a prior obstruction.

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).

Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).

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