Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions (CREDENTIAL)

Azienda Ospedaliera San Camillo Forlanini

Status and phase

Completed

Phase 2

Phase 1

Conditions

Endothelial Dysfunction

Treatments

Drug: intracoronary infusion of acetylcholine

Study type

Interventional

Funder types

Other

Identifiers

NCT01242306

CREDENTIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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