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Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

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ClinicalTrials.gov Identifier: NCT04862689
Recruitment Status : Not yet recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Vascular Solutions LLC

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: Ringer Perfusion Balloon Catheter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI. [ Time Frame: During Procedure ]
    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.

  2. Rate of clinically relevant events [ Time Frame: Discharge or 30 days, whichever comes first ]
    Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE)


Secondary Outcome Measures :
  1. Successful PCI [ Time Frame: During Procedure ]
    Final residual stenosis ≤20% diameter stenosis (in-stent) or ≤50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE.

  2. TIMI Flow [ Time Frame: During Procedure ]
    Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation

  3. Ringer Inflation [ Time Frame: During Procedure ]
    Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862689


Contacts
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Contact: Ricardo DeMedeiros, PhD 763-762-2562 ricardo.demedeiros@teleflex.com

Sponsors and Collaborators
Vascular Solutions LLC
Investigators
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Study Director: Ridardo DeMedeiros, PhD Teleflex
More Information
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Responsible Party: Vascular Solutions LLC
ClinicalTrials.gov Identifier: NCT04862689    
Other Study ID Numbers: ST3170
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases