Head-to-Head Comparison of Endothelial Dysfunction (Bare Metal Stent vs Sirolimus Eluting Stent) in the Same Patient With Multiple Coronary Artery Lesions (CREDENTIAL)

NCT01242306 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Azienda Ospedaliera San Camillo Forlanini
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	25
Start date	2009-03
Completion	2009-12

Conditions

• Endothelial Dysfunction

Interventions

• intracoronary infusion of acetylcholine

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 — 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

Countries

Italy