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

Not Applicable

Completed

Conditions: Peripheral Arterial Disease
Arterial Occlusive Diseases
Peripheral Vascular Diseases

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

Registration Number: NCT02424383

Lead Sponsor: C. R. Bard

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1005

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTA (Lutonix® 035 DCB Catheter)	PTA (Lutonix® 035 DCB Catheter)	Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure	12 months post-index procedure	TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure	30 days post index procedure	Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure	6 , 12, 24, and 36 months	TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates).
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.	6, 24, and 36 months post index procedure	TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates).
Percentage of Participants With Acute Device and Procedural Success	At time of Index Procedure	Lesion success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure	12 months post-index procedure	The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first.
Percentage of Participants With 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 at 6, 12, 24, and 36 Months Post Index Procedure	6, 12, 24, and 36 Months Post Index Procedure	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 (Kaplan-Meier estimates).
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.	6, 12, 24, and 36 Months Post Index Procedure	Freedom from major amputation of the target limb defined as above the ankle amputation

Trial Locations

Locations (72): Allegheny-Singer Research Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
The Research Foundation for Suny
🇺🇸
Syracuse, New York, United States
Vascular Access Solutions
🇺🇸
Orangeburg, South Carolina, United States
Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
Stern Cardiovascular Foundation Inc.
🇺🇸
Memphis, Tennessee, United States
Franciscan St. Francis Health
🇺🇸
Indianapolis, Indiana, United States
Mercy West Hospital
🇺🇸
Cincinnati, Ohio, United States
UCSD Health System
🇺🇸
San Diego, California, United States
Lake Martin Laser and Vein Institute
🇺🇸
Alexander City, Alabama, United States
Chandler Regional Medical Center
🇺🇸
Chandler, Arizona, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Bradenton Cardiology Center
🇺🇸
Bradenton, Florida, United States
MedStar Health Research Institute
🇺🇸
Annapolis, Maryland, United States
Sarah Cannon Research Institute, LLC
🇺🇸
Jacksonville, Florida, United States
Research Physicians Network Alliance
🇺🇸
Boynton Beach, Florida, United States
Clearwater Cardiovascular & Interventional Consultants
🇺🇸
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Vascular Interventional of Thomasville, Associates
🇺🇸
Thomasville, Georgia, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Northside Hospital, Inc
🇺🇸
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
🇺🇸
Davenport, Iowa, United States
Peoria Radiology & Research Foundation
🇺🇸
Peoria, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸
Springfield, Illinois, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Cape Cod Research Institute
🇺🇸
Hyannis, Massachusetts, United States
DLP Marquette General Hospital
🇺🇸
Marquette, Michigan, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
🇺🇸
Petoskey, Michigan, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Merit Health Wesley
🇺🇸
Hattiesburg, Mississippi, United States
Cardiovascular Associates of Delaware Valley
🇺🇸
Haddon Heights, New Jersey, United States
Freeman Health System
🇺🇸
Joplin, Missouri, United States
New York Hospital-Queens
🇺🇸
Flushing, New York, United States
Mount Sinai Beth Israel
🇺🇸
New York, New York, United States
The Feinstein Institute for Medical Research
🇺🇸
New York, New York, United States
CaroMont Heart Clinical Research
🇺🇸
Gastonia, North Carolina, United States
Carolina East Health System
🇺🇸
New Bern, North Carolina, United States
LeBauer Cardiovascular Research Foundation
🇺🇸
Greensboro, North Carolina, United States
Jobst Vascular Institute
🇺🇸
Toledo, Ohio, United States
Rex Hospital, Inc
🇺🇸
Raleigh, North Carolina, United States
Jane Phillips Memorial Medical Center
🇺🇸
Bartlesville, Oklahoma, United States
Lankenau Institute for Medical Research
🇺🇸
Bryn Mawr, Pennsylvania, United States
Saint Vincent Consultants in Cardiovascular Diseases
🇺🇸
Erie, Pennsylvania, United States
Heart Institute at Largo
🇺🇸
Harrisburg, Pennsylvania, United States
Stern Cardiovascular Foundation, Inc
🇺🇸
Germantown, Tennessee, United States
Pinnacle Health Cardiovascular Institute
🇺🇸
Wormleysburg, Pennsylvania, United States
The Miriam Hospital - A Lifespan Partner
🇺🇸
Providence, Rhode Island, United States
Houston Methodist Research Institute
🇺🇸
Houston, Texas, United States
El Paso Cardiology Associates, P.A.
🇺🇸
El Paso, Texas, United States
Methodist Health System Clinical Research Institute
🇺🇸
Dallas, Texas, United States
Lake Washington Vascular, PLLC
🇺🇸
Bellevue, Washington, United States
Sentara Medical Group
🇺🇸
Virginia Beach, Virginia, United States
Hutchinson Regional Medical Center - Hutchinson, Inc
🇺🇸
Hutchinson, Kansas, United States
St. Luke's Hospital- Phoenix
🇺🇸
Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
St. John Hospital and Medical Center
🇺🇸
Detroit, Michigan, United States
University of Oklahoma Health Science Center
🇺🇸
Oklahoma City, Oklahoma, United States
Integris Baptist Medical Center, Inc
🇺🇸
Oklahoma City, Oklahoma, United States
Providence Health & Service
🇺🇸
Portland, Oregon, United States
CAMC Health Education and Research Institute
🇺🇸
Charleston, West Virginia, United States
Columbia St. Mary's, Inc.
🇺🇸
Milwaukee, Wisconsin, United States
Bellin Memorial Hospital, Inc
🇺🇸
Green Bay, Wisconsin, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Orlando Health
🇺🇸
Orlando, Florida, United States
Kaiser Foundation Hospitals
🇺🇸
Honolulu, Hawaii, United States
Seton Heart Institute
🇺🇸
Austin, Texas, United States
Cardiovascular Specialists of Texas
🇺🇸
Austin, Texas, United States
Virginia Cardiovascular Specialists
🇺🇸
Richmond, Virginia, United States
Wisconsin Heart-Meriter
🇺🇸
Madison, Wisconsin, United States
Colorado Heart and Vascular
🇺🇸
Lakewood, Colorado, United States