RANDOMIZED CLINICAL TRIAL OF ABLUMINUS DES+ SIROLIMUS ELUTING STENT VERSUS EVEROLIMUS-ELUTING DES FOR PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH DIABETES MELLITUS: AN INVESTIGATOR-INITIATED PILOT

  • 165
    Targeted Patients
  • 110
    Abluminus DES+ group
  • 55
    Everolimus-eluting DES group
STUDY DESIGN

• To compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.
• Multi-centre, single-blinded, randomized, Investigator-initiated pilot clinical study.
• 7 Italian sites.
• Diabetic patients undergoing percutaneous coronary intervention, randomized in a 2:1 ratio.
• A total of 165 patients will be enrolled: 110 in the Abluminus DES+ group and 55 in the Everolimus-eluting DES group.

Primary Endpoint:

• In-stent neointimal volume at 9-month follow-up, measured with OCT, following PCI with Abluminus DES+ compared with in-stent neointimal volume following PCI with Everolimus-eluting DES.

PARTICIPATING SITES

48 PATIENTS ENROLLED TILL DATE

• San Raffaele Hospital, Milano (Dr. M. Montorfano)
• San Donato Hospital, Milano (Dr. Bedogni, Dr. Testa)
• Humanitas Hospital, Milano (Dr. Reimers)
• Bolognini Hospital, Seriate-BG (Dr. Tespili, Dr. Ielasi)
• Santa Chiara Hospital, Trento (Dr. Bonmassari, Dr. Muraglia)
• Sant’Anna Hospital, Catanzaro (Dr. Missiroli)
• San Matteo Hospital, Pavia (Dr. Ferrario)
• Villa San Pietro Hospital, Roma (Dr. Monti)