Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: Ringer Perfusion Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Device: Ringer Perfusion Balloon Catheter<br>* Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI. | 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. | During Procedure | 
| Rate of clinically relevant events | Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE) | Discharge or 30 days, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful PCI | Final residual stenosis ≤20% diameter stenosis (in-stent) or ≤50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE. | During Procedure | 
| TIMI Flow | Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation | During Procedure | 
| Ringer Inflation | Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics). | During Procedure |