Coronary Artery Disease, Coronary Disease, Vascular Diseases
Conditions
Brief summary
The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.
Interventions
DEVICEINVADER™ PTCA Balloon Dilatation Catheter
INVADER™ PTCA Balloon Dilatation Catheter is a single use, EO sterilized, monorail rapid exchange (RX) coronary angioplasty balloon dilatation catheter. The INVADER™ PTCA has been designed to dilate the stenotic atherosclerotic lesions in coronary arteries or bypass grafts. The INVADER™ PTCA is an interventional, non-surgical device, and considered minimally invasive.
Sponsors
Alvimedica
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be a Turkish citizen, * To be \>18 years of age, * Lesion must be successfully crossed with a guidewire without complication, * INVADER™ PTCA is used in the primary lesion treated during the procedure, * Patient has signed and dated the informed consent.
Exclusion criteria
* Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter. * Device use not consistent with Instructions for Use (IFU). * Patients concurrently participating in another medical device or pharmaceutical clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success | 48 hours after index procedure | Measurement: Percentage of lesions among all attempted lesions with: * Successful device delivery, and * Successful inflation, achievement of appropriate diameter, and deflation of the balloon, and * Decrease in the percent stenosis after balloon procedure, and * No perforation, flow-limiting dissection or reduction in TIMI flow grade, and * No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of individual components of device success | 48 hours after index procedure | — |
| Procedural success: | 48 hours after index procedure | o Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction \[MI\], and clinically indicated target lesion revascularization \[CI-TLR\]). |
| Rate of Target Lesion Failure (TLF) | 48 hours after index procedure | o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR. |
Countries
Turkey (Türkiye)
Outcome results
None listed