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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985773
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : June 9, 2022
Sponsor:
Collaborator:
Bright Research Partners
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Coronary Artery Stenosis In-stent Restenosis Device: Lacrosse NSE ALPHA coronary dilatation catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective, multi-center, single arm clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)
Actual Study Start Date : December 17, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Procedure success [ Time Frame: 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 :
  1. Percentage of subjects with angiographic procedural success [ Time Frame: 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.

  2. Percentage of subjects with a MACE [ Time Frame: 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)

  3. Percentage of subjects with stent thrombosis within the target vessel(s) [ Time Frame: At hospital discharge, an average of 1 day after procedure ]
    Using ARC-2 definitions for definite & probable

  4. Percentage of subjects with a clinically significant arrythmia [ Time Frame: At hospital discharge, an average of 1 day after procedure ]
    Defined as arrhythmia those requiring intervention

  5. Occurrence of Lacrosse NSE ALPHA balloon rupture [ Time Frame: Procedural ]
    Per device deficiency eCRF

  6. Change in minimum lumen diameter (MLD) following use of the Lacrosse NSE ALPHA catheter [ Time Frame: Procedural ]
    Measured by quantitative coronary angiography (QCA)

  7. Device procedural success (per target lesion) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985773


Contacts
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Contact: Priti Shah 781.345.9646 pshah@infraredx.com
Contact: Joan Hazen joan@brightresearchpartners.com

Locations
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United States, California
VA Palo Alto Health System Recruiting
Palo Alto, California, United States, 94304
Contact: Phyo Aung       Phyo.Aung@va.gov   
Contact: Son Nguyen       Son.Nguyen1@va.gov   
Principal Investigator: William Fearon, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Dee Mallory    859-260-4526    Dee.mallory2@bhsi.com   
Contact: Jeannie Chapman    859-260-6172    Jeannie.chapman@bhsi.com   
Principal Investigator: Tyler Richmond, MD         
United States, Minnesota
M Health Fairview Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Lori Tetrick    952-836-3549    Lori.Tetrick@fairview.org   
Contact: Jenny Lam    651-326-7105    Jenny.Lam@fairview.org   
Principal Investigator: Carmelo Panetta, MD         
Minneapolis Heart Institute - Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Elizabeth Reedy    612-863-3996    elizabeth.reedy@allina.com   
Contact: Amy McMeans    612-863-3895    amy.mcmeans@allina.com   
Principal Investigator: Emmanouil Brilakis, MD, PhD         
United States, Mississippi
Cardiology Associates Research Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Angela Long       along@nmhs.net   
Contact: Amber Jernigan       anschmitz@nmhs.net   
Principal Investigator: Barry Bertolet, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton    347-514-3366    keb2114@cumc.columbia.edu   
Contact: Giora Weisz    212-305-7060    gw2128@cumc.columbia.edu   
Principal Investigator: Giora Weisz, MD         
Cornell University Recruiting
New York, New York, United States, 10065
Contact: Dolores Reynolds    212-746-4617      
Contact: Heather Glum    212-746-4620      
Principal Investigator: Shing-Chiu Wong, MD         
St Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago, RN    516-562-6790      
Contact: Patricia Krug    516-562-6790      
Principal Investigator: Evan Shlofmitz, DO         
United States, Tennessee
Ascension Saint Thomas Heart West Recruiting
Nashville, Tennessee, United States, 37205
Contact: Jimmy Kerrigan, MD    615-269-4545      
Principal Investigator: Jimmy Kerrigan, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Pranitha Patlolla       ppatlolla@mcw.edu   
Contact: Barbara Shimada-Krouwer       bshikrouwer@mcw.edu   
Principal Investigator: Jorge Saucedo, MD, MBA         
Sponsors and Collaborators
Infraredx
Bright Research Partners
Investigators
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Principal Investigator: Mitchell Krucoff, MD Duke University
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Responsible Party: Infraredx
ClinicalTrials.gov Identifier: NCT04985773    
Other Study ID Numbers: RDX-CL-5000
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Infraredx:
Coronary dilation catheter
Percutaneous coronary artery dilatation
Non-slip Element balloon
Restenosis
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Aneurysm
Constriction, Pathologic
Dilatation, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aneurysm