N/A
Completed N=200
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
Coronary Stenosis · Coronary Artery Stenosis · In-stent restenosis
Source: ClinicalTrials.gov NCT04985773 ↗
Enrolled (actual)
200
Serious AEs
10.0%
Results posted
Jan 2024
Primary outcomePrimary: Procedure Success — 176 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Success |
176 | — |
| SECONDARY Percentage of Subjects With Angiographic Procedural Success |
197 | — |
| SECONDARY Percentage of Subjects With a MACE |
1 | — |
| SECONDARY Percentage of Subjects With Stent Thrombosis Within the Target Vessel(s) |
— | — |
| SECONDARY Percentage of Subjects With a Clinically Significant Arrhythmia |
4 | — |
| SECONDARY Occurrence of Lacrosse NSE ALPHA Balloon Rupture |
1 | — |
| SECONDARY Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter |
0.7 | — |
| SECONDARY Device Procedural Success (Per Target Lesion) |
193 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT04985773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.