The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
NCT05904951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2024-05-20
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.
Conditions
- Coronary Artery Disease
- Coronary Disease
- Vascular Diseases
Interventions
- 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.
Sponsors & Collaborators
-
Alvimedica
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2023-04-30
- Completion
- 2023-04-30
Countries
- Turkey (Türkiye)
Study Locations
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