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

June 13, 2023 updated by: Alvimedica

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Alvimedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 hours after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of individual components of device success
Time Frame: 48 hours after index procedure
48 hours after index procedure
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]).
48 hours after index procedure
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.
48 hours after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvimedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C32104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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