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Balloon Catheter

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

N/A
Waitlist Available
Led By Mitchell Krucoff, MD
Research Sponsored by Infraredx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedural
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a special tool that helps open up blocked heart arteries. It is aimed at patients with narrowed arteries who need a procedure to widen them. The tool works by inflating like a balloon inside the artery to improve blood flow.

Eligible Conditions
  • Coronary Stenosis
  • Coronary artery disease
  • Coronary Artery Stenosis
  • In-Stent Restenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedural
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedural for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedure Success
Secondary study objectives
Change in Minimum Lumen Diameter (MLD) Following Use of the Lacrosse NSE ALPHA Catheter
Device Procedural Success (Per Target Lesion)
Occurrence of Lacrosse NSE ALPHA Balloon Rupture
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)Experimental Treatment1 Intervention
Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lacrosse NSE ALPHA coronary dilatation catheter
2021
N/A
~200

Find a Location

Who is running the clinical trial?

InfraredxLead Sponsor
10 Previous Clinical Trials
4,833 Total Patients Enrolled
Bright Research PartnersIndustry Sponsor
17 Previous Clinical Trials
2,477 Total Patients Enrolled
Mitchell Krucoff, MDPrincipal InvestigatorDuke University
~50 spots leftby Dec 2025
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