Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: drug-eluting stent; Device: drug-eluting balloon

• Registration Number: NCT03899818
• Lead Sponsor: Fatebenefratelli and Ophthalmic Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-04-25
• Study Completion: 2019-02
• Study First Submitted: 2019-02-19
• Status Verified: 2019-03
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
second generation DES	drug-eluting stent	standard therapy with second generation drug-eluting stent (DES)
new generation DEB	drug-eluting balloon	drug-eluting balloon (DEB)

Primary Outcome Measures

Name	Time	Method
Verify the non-inferiority of DCB	up to 6 months	the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with changes of vessels lumen	up to 12 months	any differences between groups in terms of vascular changes to angiography.
Concentration in blood chemistry	up to 6 months	changes of concentration in blood chemistry between the groups
Number of Participants with adverse events	up to 12 months	appearance of major cardiovascular adverse events