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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03899818

Acronym

PICCOLETO II

Enrollment

240

Registered

2019-04-02

Start date

2014-01-01

Completion date

2019-02-28

Last updated

2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

small vessels, drug coated balloon

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

Interventions

DEVICEdrug-eluting balloon

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

DEVICEdrug-eluting stent

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026