Coronary Artery Stenosis, Coronary Stenosis, In-stent Restenosis
Conditions
Keywords
Coronary dilation catheter, Percutaneous coronary artery dilatation, Non-slip Element balloon, Restenosis
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.
Interventions
DEVICELacrosse NSE ALPHA coronary dilatation catheter
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.
Sponsors
Bright Research Partners
Infraredx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multi-center, single arm clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion criteria: 1. Age 18 years or older. 2. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study-related procedures. 3. Agree to not participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. 4. Clinical evidence of ischemic heart disease, stable/unstable angina, or silent ischemia. 5. Acceptable candidate for PCI and emergency coronary artery bypass grafting and is planned for possible PTCA and/or stent placement. Angiographic inclusion criteria: 6. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. 7. A maximum of two lesions, including at least one target lesion, in single or double vessel coronary artery disease. 1. If two target lesions are defined, then no non-target lesions can be treated. 2. If a single target lesion is defined, then a single non-target lesion may be treated, but if so, it must be located in a different coronary artery from the target lesion. 8. Target lesion(s) must have a reference vessel diameter between 2.0 mm and 4.0 mm by visual estimation. 9. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) \>50% by visual estimation and a fractional flow reserve (FFR) of \<0.80 or resting full-cycle ratio (RFR) or instantaneous wave-free ratio (iFR) \<0.9. 10. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion; must not, in the opinion of the investigator, impact the conduct or completion of the index procedure; and must be deemed a clinical angiographic success as visually assessed by the investigator. EXLUSION CRITERIA General
Exclusion criteria
1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, a clopidogrel non-responder, or sensitivity to contrast media that cannot be adequately pre-medicated or replaced with a clinically suitable alternative. 2. Known diagnosis of type I myocardial infarction (resulting from primary reduction of flow from a culprit lesion likely to have a thrombotic component) within 7 days prior to the index procedure. 3. Known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days prior to index procedure. 4. Planned target lesion treatment with atherectomy (rotational, orbital or laser), cutting balloon, thrombectomy, lithotripsy or an unapproved device during the index procedure. 5. Serum creatinine \>2.0 mg/dl within 7 days prior to the index procedure. 6. Cerebrovascular accident within 6 months prior to the index procedure. 7. Active peptic ulcer or active gastrointestinal bleeding within 6 months prior to the index procedure. 8. Left ventricular ejection fraction \<30% based on most recent measurement within a year of the index procedure (if LVEF is not available in the medical records, it may be obtained at the time of the index procedure, prior to enrollment). 9. Target lesion located within a bypass graft (venous or arterial) or graft anastomosis. 10. Previous percutaneous intervention, within 9 months before the study procedure, on lesions in a target vessel (including side branches) that are located within 10 mm from the current target lesion(s). 11. Target lesion(s) with complete total occlusion defined as the complete obstruction of a native coronary artery, exhibiting TIMI 0 or TIMI 1 flow, with an occlusion duration of at least 3 months. 12. Unstable hemodynamics or shock. 13. Other medical condition which might, in the opinion of the investigator, put the patient at risk or confound the results of the study. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 a Clinically Significant Arrhythmia | At hospital discharge, an average of 1 day after procedure | A clinically significant arrhythmia is defined as those requiring intervention. |
| 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. |
| 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. |
| Occurrence of Lacrosse NSE ALPHA Balloon Rupture | Procedural | Per device deficiency eCRF |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.
Lacrosse NSE ALPHA coronary dilatation catheter: 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. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) |
|---|---|
| Age, Continuous | 69.5 years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized Other | 10 Participants |
| Race/Ethnicity, Customized Subject chose not to disclose | 7 Participants |
| Race/Ethnicity, Customized White | 171 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 200 |
| other Total, other adverse events | 17 / 200 |
| serious Total, serious adverse events | 20 / 200 |
Outcome results
Primary
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
Population: Four (4) subjects had no final TIMI assessed by either the core lab or the site so are not included in the assessment of primary endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Procedure Success | 176 Participants |
Secondary
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
Population: Only subjects that had lesions were analyzed (N=147). If final diameter stenosis or MLD was not assessed by the core laboratory, due to missing imaging, site-reported data was used, if available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter | 0.7 mm |
Secondary
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
Population: Includes only those lesions in the subjects included in the primary endpoint analysis; four (4) subjects had no final TIMI assessed by either the core lab or the site so are not included in the assessment of primary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Device Procedural Success (Per Target Lesion) | 193 lesions |
Secondary
Occurrence of Lacrosse NSE ALPHA Balloon Rupture
Per device deficiency eCRF
Time frame: Procedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Occurrence of Lacrosse NSE ALPHA Balloon Rupture | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Percentage of Subjects With a Clinically Significant Arrhythmia | 4 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Percentage of Subjects With a MACE | 1 Participants |
Secondary
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
Population: Three (3) subjects were missing final diameter stenosis (both core lab and site data).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Percentage of Subjects With Angiographic Procedural Success | 197 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) | Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s) | 0 Participants |