Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

Coronary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862689
• Other study ID #: ST3170
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Vascular Solutions LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

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

Locations

Country	Name	City	State
Canada	Heart Health Institute	Scarborough	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Heath Sciences Center	Toronto	Ontario
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	St. Luke's Hospital	Kansas City	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	Torrance Memorial Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Solutions LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	TIMI Flow	Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation	During Procedure
Secondary	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