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

Alvimedica100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Coronary Artery Disease Coronary Disease Vascular Diseases

Interventions

INVADER™ PTCA Balloon Dilatation CatheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alvimedica

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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)

Time frame: 48 hours after index procedure

Secondary Outcomes

Rate of individual components of device success

Time frame: 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 \[CI-TLR\]).

Time frame: 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.

Time frame: 48 hours after index procedure

Data from ClinicalTrials.gov

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