Overview

This trial is active, not recruiting.

Conditions peripheral arterial disease, peripheral vascular diseases, arterial occlusive diseases
Treatment pta (lutonix® 035 dcb catheter)
Sponsor C. R. Bard
Start date April 2015
End date October 2017
Trial size 1004 participants
Trial identifier NCT02424383, BPV-14-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
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.

Primary Outcomes

Measure
Freedom from Target Lesion Revascularization
time frame: 12 months
Primary Safety (Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization)
time frame: 30 days

Secondary Outcomes

Measure
Target Vessel Revascularization
time frame: 6 months, 12 months, 24 months, 36 months
Freedom from Target Lesion Revascularization
time frame: 6 months, 24 months, 36 months
Acute Device and Procedural success
time frame: 6 months, 12 months, 24 months, 36 months
Primary Patency
time frame: 12 months
Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death
time frame: 6 months, 12 months, 24 months, 36 months
• Freedom from major amputation of the target limb defined as above the ankle amputation
time frame: 6 months, 12 months, 24 months, 36 months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

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)
Principal investigator Nicholas Shammas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.