CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,005 enrolled
Drug / intervention
PTA (Lutonix® 035 DCB Catheter)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02424383
NCT02424383N/ACompleted
CompareCT.gov

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)

C. R. Bard·interventional·Posted Apr 23, 2015·Updated May 22, 2020

In Brief

A clinical study evaluating PTA (Lutonix® 035 DCB Catheter) for Peripheral Arterial Disease and 2 related conditions. Completed, enrolled 1,005 participants across 73 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 23, 2015
Enrollment StartApr 23, 2015
Primary CompletionOct 27, 2017
Study CompletionOct 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.2 years ago

Interventions

PTA (Lutonix® 035 DCB Catheter)device

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.