A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

Not Applicable

Completed

Conditions: In-stent Restenosis
Coronary Stenosis
Coronary Artery Stenosis

Interventions: Device: Lacrosse NSE ALPHA coronary dilatation catheter

Registration Number: NCT04985773

Lead Sponsor: Infraredx

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)	Lacrosse NSE ALPHA coronary dilatation catheter	Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.

Primary Outcome Measures

Name	Time	Method
Procedure Success	Procedural	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s)	At hospital discharge, an average of 1 day after procedure	Stent thrombosis is defined using ARC-2 definitions for definite \& probable per CEC adjudication.
Percentage of Subjects With Angiographic Procedural Success	Procedural	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.
Percentage of Subjects With a MACE	At hospital discharge, an average of 1 day after procedure	Defined as a composite of: * All-cause death * Myocardial infarction (MI) * Clinically indicated target lesion revascularization (TLR)
Percentage of Subjects With a Clinically Significant Arrhythmia	At hospital discharge, an average of 1 day after procedure	A clinically significant arrhythmia is defined as those requiring intervention.
Occurrence of Lacrosse NSE ALPHA Balloon Rupture	Procedural	Per device deficiency eCRF
Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter	Procedural	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.
Device Procedural Success (Per Target Lesion)	Procedural	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.

Trial Locations

Locations (10): St Francis Hospital
🇺🇸
Roslyn, New York, United States
Cornell University
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Minneapolis Heart Institute - Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Cardiology Associates Research
🇺🇸
Tupelo, Mississippi, United States
Ascension Saint Thomas Heart West
🇺🇸
Nashville, Tennessee, United States
VA Palo Alto Health System
🇺🇸
Palo Alto, California, United States
M Health Fairview
🇺🇸
Maplewood, Minnesota, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States