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

Alvimedica

Status: Completed

Conditions: Coronary Artery Disease; Vascular Diseases; Coronary Disease

Treatments: Device: INVADER™ PTCA Balloon Dilatation Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT05904951

C32104

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.