This study is in progress, not accepting new patients

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

a study on Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases

Summary

for people ages 21 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)

Details

The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.

Keywords

Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Vascular Diseases PTA (Lutonix® 035 DCB Catheter)

Eligibility

You can join if…

Open to people ages 21 years and up

  1. The subject provides written informed consent using an Informed Consent Form (ICF)that is reviewed and approved by the Institutional Review Board (IRB) for the site.
  2. The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
  3. The subject is ≥ 21 years old.
  4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.

You CAN'T join if...

  1. The subject is unable or unwilling to provide informed consent.
  2. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
  3. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.

Locations

  • UCSD Health System
    San Diego California 92093 United States
  • St. Luke's Hospital- Phoenix
    Phoenix Arizona 85006 United States
  • Chandler Regional Medical Center
    Chandler Arizona 85224 United States
  • El Paso Cardiology Associates, P.A.
    El Paso Texas 79902 United States
  • Colorado Heart and Vascular
    Lakewood Colorado 80228 United States
  • Providence Health & Service
    Portland Oregon 97225 United States
  • Lake Washington Vascular, PLLC
    Bellevue Washington 98004 United States
  • Integris Baptist Medical Center, Inc
    Oklahoma City Oklahoma 73112 United States
  • University of Oklahoma Health Science Center
    Oklahoma City Oklahoma 73104 United States
  • Hutchinson Regional Medical Center - Hutchinson, Inc
    Hutchinson Kansas 67502 United States
  • Seton Heart Institute
    Austin Texas 78705 United States
  • Cardiovascular Specialists of Texas
    Austin Texas 78758 United States
  • Methodist Health System Clinical Research Institute
    Dallas Texas 75203 United States
  • Jane Phillips Memorial Medical Center
    Bartlesville Oklahoma 74006 United States
  • Houston Methodist REsearch Institute
    Houston Texas 77030 United States
  • Freeman Health System
    Joplin Missouri 64804 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
C. R. Bard
ID
NCT02424383
Study Type
Observational [Patient Registry]
Last Updated
March 2, 2018