Back to resultsInvestigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
Primary Purpose
Coronary Stenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ringer Perfusion Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenosis
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.
Sites / Locations
- Torrance Memorial Medical Center
- Brigham & Women's Hospital
- St. Luke's Hospital
- University of Washington Medical Center
- Heart Health Institute
- Sunnybrook Heath Sciences Center
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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.
TIMI Flow
Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation
Ringer Inflation
Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04862689
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Solutions LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ringer Perfusion Balloon Catheter
Intervention Description
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
Primary Outcome Measure Information:
Title
Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI.
Description
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.
Time Frame
During Procedure
Title
Rate of clinically relevant events
Description
Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE)
Time Frame
Discharge or 30 days, whichever comes first
Secondary Outcome Measure Information:
Title
Successful PCI
Description
Final residual stenosis ≤20% diameter stenosis (in-stent) or ≤50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE.
Time Frame
During Procedure
Title
TIMI Flow
Description
Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation
Time Frame
During Procedure
Title
Ringer Inflation
Description
Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).
Time Frame
During Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Lane
Organizational Affiliation
Teleflex
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kathleen Kearney, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98196
Country
United States
Facility Name
Heart Health Institute
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Sunnybrook Heath Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
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