Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: Ringer Perfusion Balloon Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Heart Health Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Heath Sciences Center
• United States
  • California
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • Washington
    • Seattle, Washington, United States, 98196
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vascular Solutions LLC
• Investigators: Study Director: Sherry Lane, Teleflex; Principal Investigator: Kathleen Kearney, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: ST3170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes