NCT03899818

Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Fatebenefratelli and Ophthalmic Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	drug-eluting balloon	Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)
DEVICE	drug-eluting stent	Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-04-25
• Completion: 2019-02-01
• First posted: 2019-04-02
• Last updated: 2019-04-02