Clinical trial NCT04862689: Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
Official title: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Lead sponsor: Vascular Solutions LLC
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI.
timeFrame: During Procedure
measure: Rate of clinically relevant events
timeFrame: Discharge or 30 days, whichever comes first
Secondary outcomes:
measure: Successful PCI
timeFrame: During Procedure
measure: TIMI Flow
timeFrame: During Procedure
measure: Ringer Inflation
timeFrame: During Procedure
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Scarborough
country: Canada
facility: Heart Health Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Heath Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Teleflex
name: Sherry Lane
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Kathleen Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References: