NCT00495664

Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction

Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: The Hospital District of Satakunta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronary-stent implantation is commonly performed for treatment of acute myocardial infarction (MI). Drug eluting stents (DES) among selected patients have been shown to reduce target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). However, there is no studies comparing titanium-nitride-oxide (TITANOX) coated stent with paclitaxel-eluting stent (PES) in acute MI.

Detailed description

Study Design and Patient Population The TITAX AMI (Titanium-Nitride-Oxide Coated stents versus Paclitaxel-Eluting Stents In Acute Myocardial Infarction) trial is a prospective, randomized and a multicenter trial conducted from December 2005 to November 2006 in six Finnish hospitals. The study was conducted according to the declaration of Helsinki and written informed consent was obtained from all patients. This protocol was approved by the Ethics Committees of the coordinating centre Satakunta Central Hospital and the participating hospitals. Patients \> 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial. Exclusion criteria included unprotected left main disease, ostial or restenotic lesions, contraindication to aspirin, clopidogrel or heparins, life expectancy of less than 12 months and if a stent longer than 28 mm was needed. According to the trial protocol, randomization was performed after visualization of the culprit lesion or a totally occluded infarct-related vessel during coronary angiography. Using sealed envelopes, patients were randomly assigned to the groups in a 1:1 ratio in each participating center.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Titan stent and Taxus-Liberte stent

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-07-03
• Last updated: 2012-09-06

Locations

1 site across 1 country: Finland