Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Alvimedica
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Device success
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Turkish citizen,
- •≥18 years of age,
- •Has indication for percutaneous transluminal coronary angioplasty (PTCA),
- •Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent
- •Fluydo NC using in the primary lesion treated during the procedure by the decision physician,
- •Has signed and dated the informed consent.
Exclusion Criteria
- •Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis.
- •Needs the device use in an unprotected left main coronary artery
- •Device use has not consistent with Instructions for Use.
- •Participating in another medical device or pharmaceutical clinical trial.
Outcomes
Primary Outcomes
Device success
Time Frame: immediately after interventional procedure
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
Time Frame: immediately after interventional procedure
Successful inflation, achievement of appropriate diameter, and deflation of the balloon
Time Frame: immediately after interventional procedure
Decrease in the percent stenosis after balloon procedure
Time Frame: immediately after interventional procedure
No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame: immediately after interventional procedure
Secondary Outcomes
- Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.(discharge or 48 hours after index procedure, whichever happens first)
- Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR))(Discharge or 48 hours after index procedure, whichever happens first)