Coronary Stenosis
Conditions
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.
Interventions
DEVICERinger Perfusion Balloon Catheter
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
Sponsors
Vascular Solutions LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| TIMI Flow | During Procedure | Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation |
| 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). |
Countries
Canada, United States
Outcome results
None listed