Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter (SAFE-DCB)

C. R. Bard

Status: Completed

Conditions: Peripheral Vascular Diseases; Arterial Occlusive Diseases; Peripheral Arterial Disease

Treatments: Device: PTA (Lutonix® 035 DCB Catheter)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02424383

BPV-14-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,005 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,005 participants in 1 patient group

PTA (Lutonix® 035 DCB Catheter)

Experimental group

Description:

Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.

Treatment:

Device: PTA (Lutonix® 035 DCB Catheter)