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

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904951
• Other study ID #: C32104
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: Alvimedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Vascular Diseases

Intervention

Device:
• INVADER™ PTCA Balloon Dilatation Catheter
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.

Locations

Country	Name	City	State
Turkey	Alvimedica	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Alvimedica

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of individual components of device success		48 hours after index procedure
Secondary	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]).	48 hours after index procedure
Secondary	Rate of Target Lesion Failure (TLF)	o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.	48 hours after index procedure