Skip to main content
OpenTrials
Completed

NCT Number: NCT05904951

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alvimedica

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INVADER™ PTCA Balloon Dilatation Catheter

Device

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.

Primary outcomes

  1. Device success

    Time frame: 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 outcomes

  1. Rate of individual components of device success

    Time frame: 48 hours after index procedure

  2. Procedural success:

    Time frame: 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]).

  3. Rate of Target Lesion Failure (TLF)

    Time frame: 48 hours after index procedure

    o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.

Sponsors and collaborators

Lead sponsor

Alvimedica

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.