Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart
Summary
Coronary artery disease (CAD) is the largest cause of death and disability in the world. Besides medicines, the principle treatment of this condition requires opening of the narrowed arteries, responsible for angina and other symptoms of the disease, by angioplasty or surgery. Introduction of metal scaffolds called 'stents' in the past few decades revolutionised the angioplasty technique, and has made it the most popular treatment today for CAD. However these stents are prone to becomin narrow and obstructed after implanataion, causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he past few years has been one of the biggest breakthroughs in the field of cardiology. However ven the current available DES are still prone to narrowing in high-risk patients, like those with diabetes, and also have a higher chance for sudden blockage by a blood clot even many years later after insertion. Thus it is important to develop technology for more efficacious and safer DES.This includes safer drugs, better stent design and delivery, and more inert platforms for drug release We hypothesise that a new stent made with nanoporous particle with better polymer for drug release will prove to be safer and more efficacious alternative to currently available DES.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Coronary Stenosis
Intervention
drug eluting nonpolymeric nanoporous stent
Location
All India Institute of Medical Sciences
New Delhi
Delhi
India
110029
Status
Recruiting
Source
All India Institute of Medical Sciences, New Delhi
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00428662
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Fractional Flow Reserve, Myocardial
The ratio of maximum blood flow to the MYOCARDIUM with CORONARY STENOSIS present, to the maximum equivalent blood flow without stenosis. The measurement is commonly used to verify borderline stenosis of CORONARY ARTERIES.
Coronary Stenosis
Narrowing or constriction of a coronary artery.
Coronary-subclavian Steal Syndrome
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.
Coronary Aneurysm
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Drug-eluting Stents
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
Clinical Trials
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month...
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atheroscler...
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of d...
Excel Drug-Eluting Stent Pilot Clinical Registry
The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
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
Drug-eluting balloon in the treatment of a recurrent in-stent restenosis of drug-eluting stent.
Although medical treatment of atherosclerotic processes as a cause of the coronary artery disease has its own fundamental role, percutaneous coronary interventions showed an impressing development due...
Fracture of coronary artery sirolimus eluting stent with formation of four aneurysms.
Coronary stent fracture is a relatively rare but potentially serious complication of coronary artery stenting, in particular with sirolimus-eluting stents. It has been recognized as one possible cause...
Dislodged and mechanically distorted stent stuck within a previously implanted drug-eluting stent.
Coronary stent loss during percutaneous coronary intervention is rare and is often associated with significant morbidity. Several retrieval techniques, overlying stent deployment and crushing, and sur...
We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients...
The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-met...
