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

NCT04985773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-12

Study results available
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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.

Conditions

  • Coronary Stenosis
  • Coronary Artery Stenosis
  • In-stent Restenosis

Interventions

DEVICE

Lacrosse NSE ALPHA coronary dilatation catheter

The Lacrosse NSE ALPHA is a rapid exchange percutaneous transluminal coronary angioplasty balloon catheter with non-slip element nylon threads that focus dilatation force to reduce balloon slippage during inflation.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Infraredx

    lead INDUSTRY

Principal Investigators

  • Mitchell Krucoff, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2022-12-16
Completion
2022-12-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985773 on ClinicalTrials.gov