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

Completed

• Conditions: Coronary Artery Disease; Vascular Diseases; Coronary Disease

• Registration Number: NCT05904951
• Lead Sponsor: Alvimedica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device success	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 Outcome Measures

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

Trial Locations

Locations (1)

Alvimedica; 🇹🇷 Istanbul, Turkey