Trials / Completed
CompletedNCT05965037
The FLUYDO NC Post Market Clinical Follow-up Study
Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Alvimedica · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter | The FLUYDO NC is a rapid exchange percutaneous transluminal non-compliant coronary angioplasty balloon catheter. It is a single use only medical device, non-implantable, non-pyrogenic and sterilized with ethylene oxide and CO2 mixture. The distal portion has a hydrophilic coating and consists of two lumens: one for balloon inflation and deflation, the other for guidewire advancement and retraction. The product is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2023-06-15
- Completion
- 2023-06-15
- First posted
- 2023-07-28
- Last updated
- 2024-05-13
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05965037. Inclusion in this directory is not an endorsement.