Clinical trial NCT01242306: Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions
Official title: Head-to-Head Comparison of Endothelial Dysfunction (Bare Metal Stent vs Sirolimus Eluting Stent) in the Same Patient With Multiple Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Endothelial Dysfunction
Keywords: endothelial dysfunction acetylcholine bms ses
Lead sponsor: Azienda Ospedaliera San Camillo Forlanini
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
Study officials:
affiliation: Azienda Ospedaliera San Camillo Forlanini
name: Violini Roberto, MD
role: STUDY_CHAIR
affiliation: European Society of Cardiology
name: Mischie Nicolae Alexandru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera San Camillo Forlanini
name: Nazzaro Marco, MD
role: STUDY_DIRECTOR
References:
citation: Mischie AN, Nazzaro MS, Fiorilli R, De Felice F, Musto C, Confessore P, Parma A, Boschetti C, Violini R. Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):E184-91. doi: 10.1002/ccd.24844. Epub 2013 Mar 5.