A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)
Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
About this trial
This is an interventional treatment trial for Coronary Stenosis focused on measuring Coronary dilation catheter, Percutaneous coronary artery dilatation, Non-slip Element balloon, Restenosis
Eligibility Criteria
INCLUSION CRITERIA
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.
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
Sites / Locations
- VA Palo Alto Health System
- Baptist Health Lexington
- M Health Fairview
- Minneapolis Heart Institute - Abbott Northwestern Hospital
- Cardiology Associates Research
- Columbia University Medical Center
- Cornell University
- St Francis Hospital
- Ascension Saint Thomas Heart West
- Medical College of Wisconsin
Arms of the Study
Arm 1
Experimental
Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)
Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.