Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

NCT04862689 | Completed DMC FDA Device

• 1 other identifier: ST3170
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

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).

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Successful PCI

  During Procedure

• TIMI Flow

  During Procedure

• Ringer Inflation

  During Procedure

Study Arms (1)

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

Interventions

Ringer Perfusion Balloon Catheter DEVICE

Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vascular Solutions LLC: lead

Study Sites (7)

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

University of Washington Medical Center

Seattle, Washington, 98196, United States

Location

Heart Health Institute

Scarborough Village, Ontario, M1B 4Z8, Canada

Location

Sunnybrook Heath Sciences Center

Toronto, Ontario, M4N3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Sherry Lane

  Teleflex

  STUDY DIRECTOR

• Kathleen Kearney, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 28, 2021
• Study Start: May 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (4)