Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

Cardiovascular Diseases Clinical Trial

— PICCOLETO II  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899818
• Other study ID #: PICCOLETO2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: February 2019

Study information

• Verified date: March 2019
• Source: Fatebenefratelli and Ophthalmic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2019
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fatebenefratelli and Ophthalmic Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with changes of vessels lumen	any differences between groups in terms of vascular changes to angiography.	up to 12 months
Secondary	Concentration in blood chemistry	changes of concentration in blood chemistry between the groups	up to 6 months
Secondary	Number of Participants with adverse events	appearance of major cardiovascular adverse events	up to 12 months