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Coronary StenosisEXPANSE-PTCANCT04985773

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

A study testing Lacrosse NSE ALPHA coronary dilatation catheter in people with Coronary Stenosis and Coronary Artery Stenosis, run by Infraredx at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lacrosse NSE ALPHA coronary dilatation catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
10 sitesUnited States
Study dates
17 Dec 2021to 16 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria:
  • 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.
Show all 45Show fewer
  • Angiographic inclusion criteria:
  • 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
  • General exclusion criteria:
  • 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.
  • Angiographic exclusion criteria
  • Target lesion(s) longer than 32 mm by visual estimation.
  • Extreme angulation (90º or greater) within 5 mm of the target lesion.
  • Target lesion(s) demonstrating flow limiting dissection (NHLBI Grade C or higher) prior to deployment of the Lacrosse NSE ALPHA.
  • Unprotected left main coronary artery disease (>50% diameter stenosis).
  • Coronary artery spasm of the target vessel in the absence of a significant stenosis.
  • Target lesion(s) with angiographic presence of probable or definite thrombus.
  • 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.
  • Target lesion(s) located in bifurcation beyond stent struts.
  • Target lesion(s) located distal to an implanted stent.
  • Target lesion(s) with stent damage.
  • 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

Who cannot join

None listed.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • M Health Fairview

    Maplewood, Minnesota, 55109

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minneapolis Heart Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205

  • Columbia University Medical Center

    New York, New York, 10032

  • Cornell University

    New York, New York, 10065

  • VA Palo Alto Health System

    Palo Alto, California, 94304

  • St Francis Hospital

    Roslyn, New York, 11576

  • Cardiology Associates Research

    Tupelo, Mississippi, 38801

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Lacrosse NSE ALPHA coronary dilatation catheter
Keywords
Coronary dilation catheter, Percutaneous coronary artery dilatation, Non-slip Element balloon, Restenosis
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lacrosse NSE ALPHA coronary dilatation catheterDevice

    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.

Study groups in NCT04985773
Study groupRoleWhat they receive
Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)ExperimentalPercutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.
Receives: Device: Lacrosse NSE ALPHA coronary dilatation catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Procedural

Secondary outcomes (7)

  1. 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.

    Measured: Procedural

  2. Percentage of Subjects With a MACE

    Defined as a composite of:

    • All-cause death
    • Myocardial infarction (MI)
    • Clinically indicated target lesion revascularization (TLR)

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

  3. 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.

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

  4. Percentage of Subjects With a Clinically Significant Arrhythmia

    A clinically significant arrhythmia is defined as those requiring intervention.

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

  5. Occurrence of Lacrosse NSE ALPHA Balloon Rupture

    Per device deficiency eCRF

    Measured: Procedural

  6. 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.

    Measured: Procedural

  7. 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.

    Measured: Procedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start17 Dec 2021
  3. Primary completion16 Dec 2022
  4. Study completion16 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A prospective, multi-center, single arm clinical study.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04985773
Sponsor's protocol ID
RDX-CL-5000
Acronym
EXPANSE-PTCA
Status last verified
Jan 2024
First submitted
21 Jul 2021
Last updated
12 Jan 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lacrosse NSE ALPHA coronary dilatation catheter in people with Coronary Stenosis and Coronary Artery Stenosis, run by Infraredx at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success (time frame: Procedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

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