Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment (PICCOLETO II)

Fatebenefratelli and Ophthalmic Hospital

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Device: drug-eluting balloon; Device: drug-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03899818

PICCOLETO2

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

new generation DEB

Other group

Description:

drug-eluting balloon (DEB)

Treatment:

Device: drug-eluting balloon

second generation DES

Other group

Description:

standard therapy with second generation drug-eluting stent (DES)

Treatment:

Device: drug-eluting stent