Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

Fatebenefratelli and Ophthalmic Hospital240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Cardiovascular Diseases

Interventions

drug-eluting balloonDEVICE

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

drug-eluting stentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Age \>18 years. 2. Stable or unstable coronary artery disease. 3. Native coronary artery lesion in vessel with diameter \<2.75 mm. 4. Clinical indication to percutaneous coronary intervention (PCI). Exclusion criteria 1. Enrolment in another study with any investigational drug or device. 2. Acute or recent (≤48 hours) myocardial infarction. 3. Creatinine clearance \<50 ml/min. 4. Left ventricle ejection fraction \<30%. 5. Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure. 6. Heavily calcified and severely tortuous lesions.

Outcomes

Primary Outcomes

Verify the non-inferiority of DCB

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).

Time frame: up to 6 months

Secondary Outcomes

Number of Participants with changes of vessels lumen

any differences between groups in terms of vascular changes to angiography.

Time frame: up to 12 months

Concentration in blood chemistry

changes of concentration in blood chemistry between the groups

Time frame: up to 6 months

Number of Participants with adverse events

appearance of major cardiovascular adverse events

Time frame: up to 12 months

Data from ClinicalTrials.gov

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