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

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

In brief

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.

Key facts

Study ID

NCT02424383

Run by

C. R. Bard

People needed

1005

Starts

2015-04-23

Expected to finish

2019-10-21

Last updated by the study team

2020-05-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is ≥ 21 years old.
• The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.

You may not qualify if…

• The subject is unable or unwilling to provide informed consent.
• The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
• 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.

Where it is running

• Chandler Regional Medical Center — Chandler, Arizona, United States
• St. Luke's Hospital- Phoenix — Phoenix, Arizona, United States
• UCSD Health System — San Diego, California, United States
• Colorado Heart and Vascular — Lakewood, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• Research Physicians Network Alliance — Boynton Beach, Florida, United States
• Bradenton Cardiology Center — Bradenton, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants — Clearwater, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Sarah Cannon Research Institute, LLC — Jacksonville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northside Hospital, Inc — Atlanta, Georgia, United States
• Vascular Interventional of Thomasville, Associates — Thomasville, Georgia, United States
• Kaiser Foundation Hospitals — Honolulu, Hawaii, United States
• Peoria Radiology & Research Foundation — Peoria, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Hutchinson Regional Medical Center - Hutchinson, Inc — Hutchinson, Kansas, United States
• Maine Medical Center — Portland, Maine, United States
• Lake Martin Laser and Vein Institute — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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