The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
The investigation is a prospective, multi-center, single arm clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll and treat 200 subjects, including a minimum of 30 subjects with in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where additional eligibility criteria will be assessed. An angiogram will be completed to assess for angiographic eligibility. If a non-target lesion is identified, it must be treated successfully prior to target lesion treatment. Once treatment of the target lesion(s) has been attempted, the subject will be considered enrolled in the study. Subjects will be followed through hospital discharge.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The Lacrosse NSE ALPHA is a rapid exchange percutaneous transluminal coronary angioplasty balloon catheter with non-slip element nylon threads that focus dilatation force to reduce balloon slippage during inflation.
VA Palo Alto Health System
Palo Alto, California, United States
Baptist Health Lexington
Lexington, Kentucky, United States
M Health Fairview
Maplewood, Minnesota, United States
Procedure Success
Defined as: * Successful delivery, inflation, deflation, and withdrawal of the study balloon; and * No evidence of device-related vessel perforation, flow limiting dissection (grade C or higher per Clinical Events Committee (CEC) adjudication) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline (per core laboratory assessment); and * Final TIMI flow grade of 3 at the conclusion of the PCI procedure per core laboratory assessment. This endpoint will be presented as the proportion of subjects experiencing device procedural success.
Time frame: Procedural
Percentage of Subjects With Angiographic Procedural Success
Defined as final diameter stenosis ≤50% in at least one of the Lacrosse NSE ALPHA attempted lesions following completion of the interventional procedure, including adjunctive stenting per core lab assessment.
Time frame: Procedural
Percentage of Subjects With a MACE
Defined as a composite of: * All-cause death * Myocardial infarction (MI) * Clinically indicated target lesion revascularization (TLR)
Time frame: At hospital discharge, an average of 1 day after procedure
Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s)
Stent thrombosis is defined using ARC-2 definitions for definite \& probable per CEC adjudication.
Time frame: At hospital discharge, an average of 1 day after procedure
Percentage of Subjects With a Clinically Significant Arrhythmia
A clinically significant arrhythmia is defined as those requiring intervention.
Time frame: At hospital discharge, an average of 1 day after procedure
Occurrence of Lacrosse NSE ALPHA Balloon Rupture
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Minneapolis Heart Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
Columbia University Medical Center
New York, New York, United States
Cornell University
New York, New York, United States
St Francis Hospital
Roslyn, New York, United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Per device deficiency eCRF
Time frame: Procedural
Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter
Measured by quantitative coronary angiography (QCA). A positive value represents an increase in MLD compared to baseline. A negative value represents a decrease in MLD compared to baseline.
Time frame: Procedural
Device Procedural Success (Per Target Lesion)
Successful delivery, inflation, deflation, and withdrawal of the study balloon; and no evidence of device-related vessel perforation, flow limiting dissection (grade C or higher) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline; and final TIMI flow grade of 3 at the conclusion of the PCI procedure. This endpoint will be presented as the proportion of target lesions experiencing device procedural success.
Time frame: Procedural