European clinical study on Sirolimus drug coated balloon in heart patients
Phase 4
Completed
- Conditions
- Health Condition 1: I20-I25- Ischemic heart diseases
- Registration Number
- CTRI/2018/12/016757
- Lead Sponsor
- Fatebenefratelli and Ophthalmic Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1) Age >18 years.
2) Patients with symptomatic coronary artery disease (including patients
with chronic stable angina, silent ischemia, and acute coronary
syndromes) with clinical indication to PCI.
3) Informed consent for the study
Exclusion Criteria
1) Patients participating in another clinical evaluation;
2) Every known allergy, intolerance or hypersensitivity to any medication used
during the procedure;
3) Target lesion severely calcific;
4) Target vessel severely tortuous.
5) preâ??dilatation not performed or unsuccessful (residual stenosis >50%);
6) Visible thrombus at lesion which is not treatable with aspiration
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to verify the rate of target vessel <br/ ><br>revascularization (TLR) at 12 months after implantation, both with new coronary <br/ ><br>angioplasty or coronary artery bypass graft.Timepoint: At 12-months.
- Secondary Outcome Measures
Name Time Method Angiographic success, defined as residual stenosis 50% and TIMI 3 coronary flow; <br/ ><br>1) procedural success, defined as angiographic success and absence of adverse <br/ ><br>cardiovascular events during initial hospitalization; <br/ ><br>2) major adverse cardiac events (MACE ), a composite endpoint of cardiac death, <br/ ><br>acute myocardial infarction and need for TLR at 6, 12 and 24 months of <br/ ><br>implantation; <br/ ><br>3) every single element determining the MACE endpoint.Timepoint: At 6,12 and 24 months