A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Stenosis; Coronary Artery Stenosis; In-stent Restenosis
• Intervention / Treatment: Device: Lacrosse NSE ALPHA coronary dilatation catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health System
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • M Health Fairview
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute - Abbott Northwestern Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Cornell University
    • Roslyn, New York, United States, 11576
      • St Francis Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Ascension Saint Thomas Heart West
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria

14. Target lesion(s) longer than 32 mm by visual estimation.
15. Extreme angulation (90º or greater) within 5 mm of the target lesion.
16. Target lesion(s) demonstrating flow limiting dissection (NHLBI Grade C or higher) prior to deployment of the Lacrosse NSE ALPHA.
17. Unprotected left main coronary artery disease (>50% diameter stenosis).
18. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
19. Target lesion(s) with angiographic presence of probable or definite thrombus.
20. Target lesion(s) involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.
21. Target lesion(s) located in bifurcation beyond stent struts.
22. Target lesion(s) located distal to an implanted stent.
23. Target lesion(s) with stent damage.

24. Non-target lesion that meets any of the following criteria:

    • Located within a bypass graft (venous or arterial)
    • Located in an unprotected left main coronary artery
    • A CTO
    • Involves a bifurcation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lacrosse NSE ALPHA percutaneous coronary intervention (PCI); Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Procedural
Percentage of Subjects With a MACE	Defined as a composite of: All-cause death; Myocardial infarction (MI); Clinically indicated target lesion revascularization (TLR)	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.	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.	At hospital discharge, an average of 1 day after procedure
Occurrence of Lacrosse NSE ALPHA Balloon Rupture	Per device deficiency eCRF	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.	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.	Procedural

Collaborators and Investigators

• Sponsor: Infraredx
• Collaborators: Bright Research Partners
• Investigators: Principal Investigator: Mitchell Krucoff, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Restenosis; Coronary dilation catheter; Percutaneous coronary artery dilatation; Non-slip Element balloon
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Aneurysm; Constriction, Pathologic; Coronary Stenosis; Dilatation, Pathologic; Coronary Aneurysm
• Other Study ID Numbers: RDX-CL-5000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes