Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease

Stopped early

Conditions studied: Coronary Disease

In brief

The main objectives of this study are define frequency of plaque shift phenomenon and impact on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting stents.

Key facts

Study ID

NCT00429052

Run by

University of Florida

People needed

24

Starts

2006-11-01

Expected to finish

2008-09-01

Last updated by the study team

2012-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient between 18-80 years of age
• Patients with a sign and/or symptoms of ischemia and new de novo lesion
• Lesion suitable for stenting
• Any bifurcation lesion with SB reference diameter(QCA) >2.3mm (MEDINA classification: 1,0,0; 0,1,0; 0,0,1; 1,1,0; 1,1,1; 0,1,1; 1,0,1)
• Only elective procedures
• Patient is willing to provide written informed consent

You may not qualify if…

• Patients treated within 72h of acute coronary syndromes (ST and non-ST elevation MI).
• Cardiogenic shock
• Lesion containing thrombus
• Total vessel occlusion involving the target vessels
• Contraindication for prolonged antiplatelet treatment
• Left main disease, venous or arterial graft disease
• Debulking technique used prior to the stent implantation
• Pregnancy
• Severe liver or renal disease (Cr>2.0)
• Life expectancy < 1 year.

Where it is running

• University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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