Clinical trial NCT04985773: A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
Official title: A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Coronary Artery Stenosis
In-stent Restenosis
Keywords: Coronary dilation catheter
Percutaneous coronary artery dilatation
Non-slip Element balloon
Restenosis
Lead sponsor: Infraredx
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2021-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, multi-center, single arm clinical study.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Procedure Success
timeFrame: Procedural
Secondary outcomes:
measure: Percentage of Subjects With Angiographic Procedural Success
timeFrame: Procedural
measure: Percentage of Subjects With a MACE
timeFrame: At hospital discharge, an average of 1 day after procedure
measure: Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s)
timeFrame: At hospital discharge, an average of 1 day after procedure
measure: Percentage of Subjects With a Clinically Significant Arrhythmia
timeFrame: At hospital discharge, an average of 1 day after procedure
measure: Occurrence of Lacrosse NSE ALPHA Balloon Rupture
timeFrame: Procedural
measure: Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter
timeFrame: Procedural
measure: Device Procedural Success (Per Target Lesion)
timeFrame: Procedural
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health System
state: California
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Maplewood
country: United States
facility: M Health Fairview
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute - Abbott Northwestern Hospital
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Nashville
country: United States
facility: Ascension Saint Thomas Heart West
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Duke University
name: Mitchell Krucoff, MD
role: PRINCIPAL_INVESTIGATOR
References: