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Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

NCT02424383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2020-05-22

Study results available
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Summary

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases
  • Arterial Occlusive Diseases

Interventions

DEVICE

PTA (Lutonix® 035 DCB Catheter)

Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Nicholas Shammas, MD · Midwest Cardiovascular Research Foundation

  • Edward Woo, MD · MedStar Regional

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-23
Primary Completion
2017-10-27
Completion
2019-10-21

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 NCT02424383 on ClinicalTrials.gov