A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Infraredx
Updated on 27 January 2023

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.

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.

Details
Condition Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
Treatment Lacrosse NSE ALPHA coronary dilatation catheter
Clinical Study IdentifierNCT04985773
SponsorInfraredx
Last Modified on27 January 2023

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