NCT00428662

Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart

Clinical and Angiographic Evaluation of Paclitaxel Eluting, Non-Polymeric, Nanoporous Carbon-Carbon Coated, Cobalt-Chromium Stent

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Stenosis

Interventions

Type	Name	Description
DEVICE	drug eluting nonpolymeric nanoporous stent

Timeline

• Start date: 2007-01-01
• Completion: 2007-10-01
• First posted: 2007-01-30
• Last updated: 2007-01-30

Locations

1 site across 1 country: India