Cardiovascular Diseases Clinical Trial
— PICCOLETO IIOfficial 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
Verified date | March 2019 |
Source | Fatebenefratelli and Ophthalmic Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fatebenefratelli and Ophthalmic Hospital |
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 |
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