Track topics on Twitter Track topics that are important to you
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem for effective long-term interventional success. This often results in repeated procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.
There is a substantial body of literature suggesting that local MYC protein production in the injured coronary artery is a major stimulus and potential cause of restenosis that appears after stent placement. This study is based upon the hypothesis that stopping MYC protein production in the vessel will help reduce restenosis (vessel re-narrowing).
AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that interferes with MYC production.
This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months.
RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery, and again 24 hours later, via slow-push intravenous administration.
The process of restenosis, the re-narrowing of a coronary artery lumen following a revascularization procedure, begins at the time of percutaneous coronary intervention (PCI). Restenosis has long been seen as a major impediment of effective long-term interventional cardiology, necessitating repeated procedures to deal with in situ recurrent stenosis of the original targeted vessel. The restenosis rates are between 30 to 50% of patients treated with balloon angioplasty and between 15 to 30% of patients treated with bare metal stents. There is currently high enthusiasm for drug-eluting stents already approved for the market and which have an overall restenosis rate of < 3% as reported in published reports for most clinical trial patient populations. However, there are subsets of patients (e.g., diabetic patients and patients with diffuse small vessel disease) that have restenosis rates around 10% despite the use of drug-eluting stents. It is probably too early to conclude that the currently approved drug-eluting stents are a panacea to relieve coronary arterial obstruction due to atherosclerotic heart disease. In fact, with the increased usage of the current drug-eluting stents on the market, there are reports of problems such as late stent malposition, subacute and late thromboses, and aneurysm formations due to the vessel toxicity associated with this method of treatment. There remains a definite need for a simple, safe and durable solution to restenosis.
The development of devices such as intravascular ultrasound has led to a greater understanding of restenosis mechanisms, especially after coronary artery stenting. It is presumed that the pathogenesis of coronary artery restenosis after a revascularization procedure entails two major processes. The first component (viz., recoil and remodeling) involves the mechanical collapse and constriction of the treated vessel; however, coronary stents provide luminal scaffolding that eliminates recoil and remodeling. The second component of coronary artery restenosis after a revascularization procedure is the endothelial response to injury. Whereas, the former focus in modulating the pathophysiological mechanisms involved in restenosis centered mainly on inhibition of platelet aggregation and function, current targets of pharmaceutical agents for this condition have shifted to inhibitors of the cell cycle, smooth muscle cell proliferation and migration, synthesis of extra-cellular matrix, and inflammatory mediators. Many different agents are currently being evaluated in pre-clinical and clinical studies.
AVI-4126, the active ingredient of RESTEN-MP, is a proprietary antisense drug designed to
interrupt the translation of the human
This clinical study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce in-stent restenosis following balloon angioplasty. In order to objectively assess the therapeutic value of RESTEN-MP compared to other drugs used in combination with coronary artery stents and to utilize a sensitive method to assess the effectiveness of RESTEN-MP as a neointimal hyperplasia inhibitor, late loss between the time of stent placement and 6 months later is the therapeutic endpoint in this study.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Coronary Artery Disease
Coburg Hospital - Cardiology Clinic
AVI BioPharma, Inc.
Published on BioPortfolio: 2014-08-27T03:47:52-0400
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a ma...
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental an...
Coronary artery disease is the leading cause of death in USA. Contemporary cardiac care has substantially reduced mortality and morbidity in patients with severe coronary artery disease. H...
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to se...
The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients...
Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical the...
Coronary revascularization for coronary artery disease dates to the introduction of coronary bypass surgery by Favaloro in 1967 and coronary angioplasty by Gruentzig in 1977 and first published in 196...
Comparative outcomes of coronary-artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease were previously reported. However, data on very...
A wider angle between the left anterior descending coronary artery (LAD) and left circumflex coronary artery (LCX) has been suggested to induce plaque formation in the arterial system via changes in s...
Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary...
Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.
A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.
A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.
Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...