Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: drug-eluting balloon
* Device: drug-eluting stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with changes of vessels lumen | any differences between groups in terms of vascular changes to angiography. | up to 12 months | 
| Concentration in blood chemistry | changes of concentration in blood chemistry between the groups | up to 6 months | 
| Number of Participants with adverse events | appearance of major cardiovascular adverse events | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small vessels, drug coated balloon