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

NCT04985773 | Completed Results FDA Device

• 1 other identifier: RDX-CL-5000
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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.

Conditions

Coronary Stenosis; Coronary Artery Stenosis; In-stent Restenosis

Keywords

Coronary dilation catheter; Percutaneous coronary artery dilatation; Non-slip Element balloon; Restenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of Subjects With Angiographic Procedural Success

  Procedural

• Percentage of Subjects With a MACE

  At hospital discharge, an average of 1 day after procedure

• Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s)

  At hospital discharge, an average of 1 day after procedure

• Percentage of Subjects With a Clinically Significant Arrhythmia

  At hospital discharge, an average of 1 day after procedure

• Occurrence of Lacrosse NSE ALPHA Balloon Rupture

  Procedural

Study Arms (1)

Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)

EXPERIMENTAL

Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.

Device: Lacrosse NSE ALPHA coronary dilatation catheter

Interventions

Lacrosse NSE ALPHA coronary dilatation catheter DEVICE

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.

Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Willing to provide written informed consent and written HIPAA authorization prior to initiation of study-related procedures.
• Agree to not participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
• Clinical evidence of ischemic heart disease, stable/unstable angina, or silent ischemia.
• Acceptable candidate for PCI and emergency coronary artery bypass grafting and is planned for possible PTCA and/or stent placement.
• De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
• A maximum of two lesions, including at least one target lesion, in single or double vessel coronary artery disease.
• If two target lesions are defined, then no non-target lesions can be treated.
• 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.
• Target lesion(s) must have a reference vessel diameter between 2.0 mm and 4.0 mm by visual estimation.
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• Known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days prior to index procedure.
• Planned target lesion treatment with atherectomy (rotational, orbital or laser), cutting balloon, thrombectomy, lithotripsy or an unapproved device during the index procedure.
• Serum creatinine \>2.0 mg/dl within 7 days prior to the index procedure.
• Cerebrovascular accident within 6 months prior to the index procedure.
• Active peptic ulcer or active gastrointestinal bleeding within 6 months prior to the index procedure.
• 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).
• Target lesion located within a bypass graft (venous or arterial) or graft anastomosis.
• 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).
• 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.
• Unstable hemodynamics or shock.
• Other medical condition which might, in the opinion of the investigator, put the patient at risk or confound the results of the study.
• Target lesion(s) longer than 32 mm by visual estimation.
• Extreme angulation (90º or greater) within 5 mm of the target lesion.

Sponsors & Collaborators

• Infraredx: lead
• Bright Research Partners: collaborator

Study Sites (10)

VA Palo Alto Health System

Palo Alto, California, 94304, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

M Health Fairview

Maplewood, Minnesota, 55109, United States

Location

Minneapolis Heart Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Cardiology Associates Research

Tupelo, Mississippi, 38801, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cornell University

New York, New York, 10065, United States

Location

St Francis Hospital

Roslyn, New York, 11576, United States

Location

Ascension Saint Thomas Heart West

Nashville, Tennessee, 37205, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Priti Shah
• Organization: Infraredx, A Nipro Company

pshah@infraredx.com

781-345-9646

Study Officials

• Mitchell Krucoff, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multi-center, single arm clinical study.

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 2, 2021
• Study Start: December 17, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)