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

Completed · Not applicable

Conditions studied: Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis

In brief

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.

Key facts

Study ID

NCT04985773

Run by

Infraredx

People needed

200

Starts

2021-12-17

Expected to finish

2022-12-16

Last updated by the study team

2024-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• VA Palo Alto Health System — Palo Alto, California, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• M Health Fairview — Maplewood, Minnesota, United States
• Minneapolis Heart Institute - Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Cardiology Associates Research — Tupelo, Mississippi, United States
• Columbia University Medical Center — New York, New York, United States
• Cornell University — New York, New York, United States
• St Francis Hospital — Roslyn, New York, United States
• Ascension Saint Thomas Heart West — Nashville, Tennessee, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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