Skip to main content
OpenTrials
Completed

NCT Number: NCT03899818

Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years.
  • Stable or unstable coronary artery disease.
  • Native coronary artery lesion in vessel with diameter <2.75 mm.
  • Clinical indication to percutaneous coronary intervention (PCI).

Exclusion criteria

  • Enrolment in another study with any investigational drug or device.
  • Acute or recent (≤48 hours) myocardial infarction.
  • Creatinine clearance <50 ml/min.
  • Left ventricle ejection fraction <30%.
  • Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
  • Heavily calcified and severely tortuous lesions.

Treatment and study plan

Drug-eluting balloon

Device

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

Drug-Eluting Stent

Device

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

Primary outcomes

  1. Verify the non-inferiority of DCB

    Time frame: 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 outcomes

  1. Number of Participants with changes of vessels lumen

    Time frame: up to 12 months

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

  2. Concentration in blood chemistry

    Time frame: up to 6 months

    changes of concentration in blood chemistry between the groups

  3. Number of Participants with adverse events

    Time frame: up to 12 months

    appearance of major cardiovascular adverse events

Sponsors and collaborators

Lead sponsor

Fatebenefratelli and Ophthalmic Hospital

Other

Registry information

Official study title

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

Acronym: PICCOLETO II

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.