Head-to-Head Comparison of Endothelial Dysfunction (Bare Metal Stent vs Sirolimus Eluting Stent) in the Same Patient With Multiple Coronary Artery Lesions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine
Study Overview
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. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.
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 february 2009 to may 2009 we aim to enroll 20 patients with at least two de novo significant angiographic stenoses in different coronary segments who will have similar diameter and length. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
BMS arm
bare metal stent arm
Intervention: intracoronary infusion of acetylcholine (Drug)
SES arm
sirolimus eluting stent arm
Intervention: intracoronary infusion of acetylcholine (Drug)
Outcomes
Primary Outcomes
evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine
Time Frame: 6 months
evaluation of change in vessel diameters (vasoconstriction or vasodilatation) in proximal and distal stent territories, after intracoronary acetylcholine infusion, having as reference the baseline diameters, for the BMS artery vs the SES artery
Secondary Outcomes
No secondary outcomes reported