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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04862689
Other study ID # ST3170
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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