Coronary StenosisNCT04862689
Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
A study testing Ringer Perfusion Balloon Catheter in people with Coronary Stenosis, run by Vascular Solutions LLC at 7 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Ringer Perfusion Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 May 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
St. Luke's Hospital
Kansas City, Missouri, 64111
University of Washington Medical Center
Seattle, Washington, 98196
Torrance Memorial Medical Center
Torrance, California, 90505
Canada3 sites
Heart Health Institute
Scarborough Village, Ontario, M1B 4Z8
Sunnybrook Heath Sciences Center
Toronto, Ontario, M4N3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
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).
Read the 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.
- Conditions
- Coronary Stenosis
- Being tested
- Ringer Perfusion Balloon Catheter
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer Perfusion Balloon CatheterDevice
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ringer Perfusion Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Discharge or 30 days, whichever comes first
Secondary outcomes (3)
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.
Measured: During Procedure
TIMI Flow
Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation
Measured: During Procedure
Ringer Inflation
Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 May 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherry Lane, Study director, TeleflexKathleen Kearney, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862689
- Sponsor's protocol ID
- ST3170
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
- ClinicalTrials.gov ID
- NCT04862689
- Acronym / sponsor ID
- ST3170
- Conditions
- Coronary Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vascular Solutions LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Ringer Perfusion Balloon CatheterAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer Perfusion Balloon CatheterNon-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter. | Device | Experimental |
Primary outcome
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.
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)
3 secondary outcomes
Successful PCI
Time frame: During Procedure
TIMI Flow
Time frame: During Procedure
Ringer Inflation
Time frame: During Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Lane study director
Teleflex
Kathleen Kearney, MD principal investigator
University of Washington
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer Perfusion Balloon Catheter in people with Coronary Stenosis, run by Vascular Solutions LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI. (time frame: During Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.