Status:
TERMINATED
Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease
Lead Sponsor:
University of Florida
Conditions:
Coronary Disease
Eligibility:
All Genders
18-80 years
Brief Summary
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 si...
Detailed Description
Percutaneous coronary intervention of bifurcation lesion remains a challenge, even in the era of drug eluting stents (DES). Bifurcation interventions, when compared with non-bifurcation interventions,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00429052
Start Date
November 1 2006
End Date
September 1 2008
Last Update
March 7 2012
Active Locations (1)
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1
University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories
Jacksonville, Florida, United States, 32209