Drug-Eluting Stent Study Evaluating a New Technology in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage
Evaluating the Svelte Drug Eluting Stent-on-a-Wire (DESOAW) in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage
Svelte Medical Systems, Inc.
30 participants
Nov 2, 2011
Interventional
Conditions
Summary
The objective of this trial is to assess the safety and clinical performance of the novel Svelte DESOAW Coronary Stent System with fully bioerodable drug carrier eluting the well-studied drug compound sirolimus in patients with single de novo coronary artery lesions.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The percutaneous revascularization of native coronary arteries exhibiting stenotic lesion(s) using a novel sirolimus-eluting cobalt chromium stent with bioerodable drug carrier delivered via fixed-wire catheter system is similar to current stenting procedures. Depending on difficulty of lesion treatment, procedures, typcially under conscious sedation, take between 30 and 90 minutes and are conducted in the cardiology cath lab. A small puncture in the groin or arm provides arterial access to place a stent in the heart using x-ray fluoroscopy for visualization during the procedure. Ususally this is a one-time procedure; however, some patients experience re-clogging of the target artery and have to return for reinitervention.
Locations(3)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12611001131943