Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
- Conditions
- Coronary Stenosis
- Interventions
- Device: Ringer Perfusion Balloon Catheter
- Registration Number
- NCT04862689
- Lead Sponsor
- Vascular Solutions LLC
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Ringer Perfusion Balloon Catheter Adult subjects clinically indicated for non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure that, in the physician's estimation, requires prolonged balloon inflation with distal perfusion.
- Primary Outcome Measures
Name Time Method Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI. During Procedure Successful delivery, inflation, deflation and withdrawal of the Ringer device; final thrombolysis in myocardial infarction (TIMI) flow grade of 3 at the conclusion of the PCI procedure.
Rate of clinically relevant events Discharge or 30 days, whichever comes first Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE)
- Secondary Outcome Measures
Name Time Method TIMI Flow During Procedure Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation
Successful PCI During Procedure Final residual stenosis ≤20% diameter stenosis (in-stent) or ≤50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE.
Ringer Inflation During Procedure Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).
Trial Locations
- Locations (7)
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Sunnybrook Heath Sciences Center
🇨🇦Toronto, Ontario, Canada
Heart Health Institute
🇨🇦Scarborough, Ontario, Canada
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University of Washington Medical Center
🇺🇸Seattle, Washington, United States