The Valentines Trial
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01066832
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:16:00-0400
Clinical Trials
A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
The purpose of this study is to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following ...
Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon ...
Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to...
The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective ...
PubMed Articles
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...
Animal studies have indicated that olfactomedin 2 (OLFM2) is involved in the process of vascular remolding. The aim of the present study was to investigate circulating OLFM2 levels in lower extremity ...
Gastric cancer (GC) is the most lethal malignancy in the digestive system. This study investigated an antibody-nanoparticle conjugate (ANC) constructed with trastuzumab (Herceptin®) and nanoparticle ...
Nanoparticle albumin-bound (nab)-paclitaxel was developed to improve paclitaxel solubility and does not need premedication to avoid infusion-related reactions associated with solvent-based (sb)-paclit...
Medical and Biotech [MESH] Definitions
Albumin-bound Paclitaxel
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
Coronary Restenosis
Recurrent narrowing or constriction of a coronary artery following surgical procedures performed to alleviate a prior obstruction.
Paclitaxel
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
Epothilones
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).
Taxus
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).
