Status:
COMPLETED
Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions
Lead Sponsor:
Azienda Ospedaliera San Camillo Forlanini
Conditions:
Endothelial Dysfunction
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. ...
Detailed Description
This prospective, randomised study compares the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. From fe...
Eligibility Criteria
Inclusion
- stable angina pectoris
- at least two significant angiographic stenoses in different native coronary vessels or in the same vessel but two different ramifications with similar diameter
- non-surgical patients
Exclusion
- acute coronary syndromes
- myocardial infarction within 3 months from event
- clinical or angiographic coronary vasospasm
- coronary angiographic findings of a fresh thrombus in the initial angiography (filling defect proximal to or involving the stenosis)
- coronary anatomy unsuitable for for intracoronary acetylcholine testing (left main coronary artery disease \>30%, surgical three vessel disease or other anatomical considerations that make it unsafe to perform intracoronary studies)
- progression of lesions or development of de novo lesions in nontarget lesions or vessels on follow-up angiography
- patients with a vessel diameter \< 2,50 mm and length lesions \<10 and \>30 mm.
- patients with vessel diameter difference (SES vs BMS) \>0,5mm and length difference of the stenosis \>50%
- lesions treated with balloon injury \<10 mm or \>50 mm in length
- severe left ventricular (LV) systolic dysfunction
- bifurcation/ostial
- presence of an unhealed dissection identified by intravascular ultrasound (IVUS) performed at the end of the study.
- angiographic restenosis in follow-up angiography
- patients with severe risk factors for endothelial dysfunction: severe renal failure, life expectancy less than 1 year, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure \>180mmHg), currently smoking, uncontrolled hypercholesterolemia (total cholesterol \>240mg/dl)
- any contraindication/nontolerance to the use of aspirin, heparin and/or clopidogrel
- lack of consent to participate
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01242306
Start Date
March 1 2009
End Date
December 1 2009
Last Update
November 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera San Camillo Forlanini
Roma, Roma, Italy, 00151