NCT03899818

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

February 19, 2019

Last Update Submit

April 1, 2019

Conditions

Cardiovascular Diseases

Keywords

small vesselsdrug coated balloon

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to 6 months

Secondary Outcomes (3)

  • Number of Participants with changes of vessels lumen

    up to 12 months

  • Concentration in blood chemistry

    up to 6 months

  • Number of Participants with adverse events

    up to 12 months

Study Arms (2)

new generation DEB

OTHER

drug-eluting balloon (DEB)

Device: drug-eluting balloon

second generation DES

OTHER

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

Device: drug-eluting stent

Interventions

drug-eluting balloonDEVICE

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

new generation DEB
drug-eluting stentDEVICE

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

second generation DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fezzi S, Trevisanello A, Buccheri D, Borgi M, Orrego PS, Zoccai GB, Cortese B. Physiological Performance of Drug-Coated Balloons in Small Coronary Arteries PICCOLETO II muFR. Catheter Cardiovasc Interv. 2025 Feb;105(3):643-649. doi: 10.1002/ccd.31376. Epub 2024 Dec 24.

    PMID: 39718036DERIVED

  • Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.

    PMID: 37164603DERIVED

  • Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25.

    PMID: 33248978DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, A.O. Fatebenefratelli Milano, Italy

Study Record Dates

First Submitted

February 19, 2019

First Posted

April 2, 2019

Study Start

January 1, 2014

Primary Completion

April 25, 2018

Study Completion

February 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03