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

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ClinicalTrials.gov Identifier: NCT03899818
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: drug-eluting balloon Device: drug-eluting stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : February 2019

Arm Intervention/treatment
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)

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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Concentration in blood chemistry [ Time Frame: up to 6 months ]
    changes of concentration in blood chemistry between the groups

  3. Number of Participants with adverse events [ Time Frame: up to 12 months ]
    appearance of major cardiovascular adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Bernardo Cortese, Principal Investigator, A.O. Fatebenefratelli Milano, Italy, Fatebenefratelli and Ophthalmic Hospital
ClinicalTrials.gov Identifier: NCT03899818     History of Changes
Other Study ID Numbers: PICCOLETO2
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital:
small vessels
drug coated balloon

Additional relevant MeSH terms:
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Cardiovascular Diseases