The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study

Study Overview
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Brief Summary
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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.

Official Title
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Balloon Dilatation Catheter for the Dilation of Stenotic Atherosclerotic Lesions in Coronary Artery or Bypass Grafts: Evaluation of Safety and Performance in Everyday Clinical Practice. The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study

Conditions
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Coronary Artery Disease, Coronary Disease, Vascular Diseases

Intervention / Treatment
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* Device: INVADER™ PTCA Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: INVADER™ 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | 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) | 48 hours after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of individual components of device success |  | 48 hours after index procedure | 
| Procedural success: | 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]). | 48 hours after index procedure | 
| Rate of Target Lesion Failure (TLF) | o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR. | 48 hours after index procedure |