Trials / Completed
CompletedNCT04862689
Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Vascular Solutions LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to demonstrate safe and effective use of the Ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (PCI).
Detailed description
A prospective, multicenter, single-arm clinical study. The study will be conducted in 3 to 5 investigational sites in the US and Canada and will enroll up to 60 participants. The population for this study is adult participants undergoing non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ringer Perfusion Balloon Catheter | Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter. |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2021-04-28
- Last updated
- 2023-12-22
Locations
7 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04862689. Inclusion in this directory is not an endorsement.