Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
NCT ID: NCT04862689
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-05-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Ringer Perfusion Balloon Catheter
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
Interventions
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Ringer Perfusion Balloon Catheter
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Vascular Solutions LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Sherry Lane
Role: STUDY_DIRECTOR
Teleflex
Kathleen Kearney, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Torrance Memorial Medical Center
Torrance, California, 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
Heart Health Institute
Scarborough Village, Ontario, Canada
Sunnybrook Heath Sciences Center
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ST3170
Identifier Type: -
Identifier Source: org_study_id