Device Trial Participant Snapshot: Lacrosse NSE ALPHA Coronary Dilatation Catheter
Device Category: Cardiovascular
Summary:
What is this device used for?
The Lacrosse NSE ALPHA Coronary Dilatation Catheter is a medical tool known as a scoring balloon (a tiny balloon with threads or ridges on it) used by doctors to help improve blood flow in the heart. It's mainly for adults who have a partly blocked heart artery. This device helps open up the artery so blood can flow better.
How is the device used?
Doctors use this device during a procedure called percutaneous coronary intervention (PCI). It involves guiding the catheter (a flexible tube) through a blood vessel to the heart where the artery is partly blocked. Once in place, the balloon inflates to widen the artery. Three plastic threads on the outside of the balloon make it easier to break through hard or tough areas.
What are the benefits of this device?
The benefits of the Lacrosse NSE ALPHA are likely to be the same as other scoring balloons. The extra force applied by the threads may allow the doctor to widen the artery more than with a traditional balloon catheter.
What are the risks and potential harmful side effects of this device?
The main risk is damage to the artery, which could cause a heart attack or serious bleeding. One patient’s artery was damaged in the clinical trial, but the patient recovered with no long-term problems.
Demographics Snapshot:
Figure 1. Participant Demographics by Sex
Figure 2. Participant Demographics by Race
Figure 3. Participant Demographics by Ethnicity
Table 1: Participant Demographics
Category | Average | Range |
---|---|---|
Age (years) | 69.5 | 32-93 |
Number of Participants | Percentage (%) | |
Sex | ||
Male | 157 | 78.5% |
Female | 43 | 21.5% |
Race | ||
American Indian or Alaskan Native | 1 | 0.5% |
Asian | 3 | 1.5% |
Black or African American | 8 | 4.0% |
White | 171 | 85.5% |
Other | 10 | 5.0% |
Unknown | 7 | 3.5% |
Ethnicity | ||
Hispanic or Latino | 7 | 3.5% |
Non-Hispanic or Latino | 183 | 91.5% |
Unknown or not reported | 11 | 2.7% |
Who participated in the clinical trial studies?
The clinical study included adult patients with partly blocked coronary arteries. The trial helped determine if the device was safe and effective. For more information about the demographics of all participants, please see Table 1.
What did the trials evaluate?
The trial was designed to measure how often the Lacrosse NSE ALPHA was successful at opening the artery. If the device was unable to reach the area, blood flow did not improve, or if the device caused a serious injury to the artery, it was not counted as successful.
Were there any differences in how well the device worked or risks among different sexes, races, ethnicities, and age groups?
While we know the sex, age range, race, and ethnicity of the study participants, we do not have information on whether there were differences in benefits in various groups. There was only one injury.
Summary for Clinical Audiences
The trial was a multi-center, single arm study that followed adult patients through hospital discharge. A prespecified performance goal for device procedural success was created based on the results of previous studies of scoring balloons. This goal was not met because the device was unable to cross several challenging lesions. The totality of the data allowed FDA to conclude that the benefits of the device still outweigh the risks and a post approval study will examine whether additional guide catheter support improves lesion crossing success rates.