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

Phase 1/2 Completed 25 enrolled Azienda Ospedaliera San Camillo Forlanini

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2009-03
Primary completion: 2009-11
Completion: 2009-12

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetylcholine	Small molecule	140 ug	Other
Comparator	Isosorbide Dinitrate	Other / unclassified	2 mg	Other
Comparator	nitroglycerine	Unknown	250 ug	Other

Indications

No indication recorded.