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

April 1, 2019 updated by: Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: new generation DEB
drug-eluting balloon (DEB)
Device: drug-eluting balloon
Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)
OTHER: second generation DES
standard therapy with second generation drug-eluting stent (DES)
Device: drug-eluting stent
Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
Concentration in blood chemistry
Time Frame: up to 6 months
changes of concentration in blood chemistry between the groups
up to 6 months
Number of Participants with adverse events
Time Frame: up to 12 months
appearance of major cardiovascular adverse events
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatebenefratelli and Ophthalmic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

April 25, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICCOLETO2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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