Trial Outcomes & Findings for A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (NCT NCT04985773)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

Procedural

Results posted on

2024-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	200
Overall Study COMPLETED	199
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 Participants 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.
Age, Continuous	69.5 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants
Race/Ethnicity, Customized White	171 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Subject chose not to disclose	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=196 Participants 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.
Procedure Success	176 Participants

SECONDARY outcome

Timeframe: Procedural

Population: Three (3) subjects were missing final diameter stenosis (both core lab and site data).

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.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=197 Participants 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.
Percentage of Subjects With Angiographic Procedural Success	197 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 Participants 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.
Percentage of Subjects With a MACE	1 Participants

SECONDARY outcome

Timeframe: At hospital discharge, an average of 1 day after procedure

Stent thrombosis is defined using ARC-2 definitions for definite \& probable per CEC adjudication.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 Participants 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.
Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s)	0 Participants

SECONDARY outcome

Timeframe: At hospital discharge, an average of 1 day after procedure

A clinically significant arrhythmia is defined as those requiring intervention.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 Participants 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.
Percentage of Subjects With a Clinically Significant Arrhythmia	4 Participants

SECONDARY outcome

Timeframe: Procedural

Per device deficiency eCRF

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 Participants 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.
Occurrence of Lacrosse NSE ALPHA Balloon Rupture	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=158 lesions 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.
Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter	0.7 mm Interval 0.1 to 2.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=216 lesions 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.
Device Procedural Success (Per Target Lesion)	193 lesions

Adverse Events

Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI)

Serious events: 20 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 participants at risk 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.
Cardiac disorders Myocardial infarction	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Vascular disorders Arterial dissection	2.0% 4/200 • Number of events 4 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Injury, poisoning and procedural complications Hematoma, access site, >5 cm	1.0% 2/200 • Number of events 2 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
General disorders Blood loss from puncture site	1.0% 2/200 • Number of events 2 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
General disorders Chest pain, non-cardiac	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Vascular disorders Hypotension	1.0% 2/200 • Number of events 2 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Cardiac disorders Arrhythmia, bradycardia	1.0% 2/200 • Number of events 2 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Cardiac disorders Arrhythmia, other	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Vascular disorders Arterial perforation	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Vascular disorders Hypertension	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
General disorders Other, chest pain	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Vascular disorders Arterial occlusion of the second diagonal	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Gastrointestinal disorders Hematamesis	0.50% 1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).

Other adverse events

Other adverse events
Measure	Lacrosse NSE ALPHA Percutaneous Coronary Intervention (PCI) n=200 participants at risk 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.
Vascular disorders Arterial dissection	8.5% 17/200 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).

Additional Information

Priti Shah

Infraredx, A Nipro Company

Phone: 781-345-9646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place