Status:
COMPLETED
Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
Lead Sponsor:
Vascular Solutions LLC
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 interventi...
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 s...
Eligibility Criteria
Inclusion
- Male and Female subjects \>18 years old.
- Patients undergoing clinically indicated non-emergent PCI as a stand-alone procedure or in combination with diagnostic angiography during the same procedure.
- Study target lesion characteristics: a) native de-novo coronary stenosis of at least 70% visually estimated stenosis, or at least 50% visually estimated stenosis and shown to be physiologically significant by flow-mediated criteria (FFR \<0.80, IFR \<0.91); b) estimated reference vessel diameter 2.0-4.5mm; c) lesion length \<25mm; d) calcification not greater than mild.
- Per investigator assessment, the patient may benefit from inflation distal perfusion during balloon inflation. Examples include, but are not limited to: (i) LV systolic dysfunction with LVEF\<50% by any modality; (ii) a territory subtended by the target vessel downstream from the target lesion that is estimated to be in excess of 25% of viable LV mass; (iii) prior hemodynamic or electrical instablility during intervention on the target lesion; (iv) the potential to avoid placement of a coronary stent if a stent-like result can be achieved through prolonged balloon inflation.
- Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception.
- Informed consent provided.
Exclusion
- Hemodynamic or arrhythmic instability within 48 hours or a myocardial infarction within 72 hours of PCI.
- More than 2 lesions planned during index PCI.
- Procedural complication developing prior to PCI of study target.
- Ejection fraction (EF) \<25%.
- Creatinine clearance (Cr-Cl) \<25 mg/dL.
- Baseline flow at study target \<TIMI-2.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04862689
Start Date
May 1 2022
End Date
June 30 2023
Last Update
December 22 2023
Active Locations (7)
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1
Torrance Memorial Medical Center
Torrance, California, United States, 90505
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
4
University of Washington Medical Center
Seattle, Washington, United States, 98196