The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFirst Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedMay 20, 2024
May 1, 2024
5 months
May 30, 2023
May 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Rate of individual components of device success
48 hours after index procedure
Procedural success:
48 hours after index procedure
Rate of Target Lesion Failure (TLF)
48 hours after index procedure
Interventions
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 Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvimedicalead
Study Sites (1)
Alvimedica
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 15, 2023
Study Start
December 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
May 20, 2024
Record last verified: 2024-05