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

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)

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 Overview

• Status: Completed
• Conditions: Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Intervention / Treatment: Device: PTA (Lutonix® 035 DCB Catheter)

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.

• Study Type: Interventional
• Enrollment (Actual): 1005
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Lake Martin Laser and Vein Institute
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Hospital- Phoenix
  • California
    • San Diego, California, United States, 92093
      • UCSD Health System
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Health Research Institute
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Physicians Network Alliance
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular & Interventional Consultants
    • Jacksonville, Florida, United States, 32207
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Sarah Cannon Research Institute, LLC
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital, Inc
    • Thomasville, Georgia, United States, 31792
      • Vascular Interventional of Thomasville, Associates
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Foundation Hospitals
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Peoria Radiology & Research Foundation
    • Springfield, Illinois, United States, 62701
      • Prairie Education and Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Regional Medical Center - Hutchinson, Inc
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • MedStar Health Research Institute
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Marquette, Michigan, United States, 49855
      • DLP Marquette General Hospital
    • Petoskey, Michigan, United States, 49770
      • Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Merit Health Wesley
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Freeman Health System
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of Delaware Valley
    • Neptune, New Jersey, United States, 07754
      • Jersey Shore University Medical Center
  • New York
    • Flushing, New York, United States, 11355
      • New York Hospital-Queens
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel
    • New York, New York, United States, 10075
      • The Feinstein Institute for Medical Research
    • Syracuse, New York, United States, 13210
      • The Research Foundation for Suny
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • CaroMont Heart Clinical Research
    • Greensboro, North Carolina, United States, 27401
      • LeBauer Cardiovascular Research Foundation
    • New Bern, North Carolina, United States, 28562
      • Carolina East Health System
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Mercy West Hospital
    • Toledo, Ohio, United States, 43603
      • Jobst Vascular Institute
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Jane Phillips Memorial Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center, Inc
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Health & Service
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Lankenau Institute for Medical Research
    • Erie, Pennsylvania, United States, 16502
      • Saint Vincent Consultants in Cardiovascular Diseases
    • Harrisburg, Pennsylvania, United States, 17110
      • Heart Institute at Largo
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny-Singer Research Institute
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital - A Lifespan Partner
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Vascular Access Solutions
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation, Inc
    • Memphis, Tennessee, United States, 38120
      • Stern Cardiovascular Foundation Inc.
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Heart Institute
    • Austin, Texas, United States, 78758
      • Cardiovascular Specialists of Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System Clinical Research Institute
    • El Paso, Texas, United States, 79902
      • El Paso Cardiology Associates, P.A.
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Virginia Cardiovascular Specialists
    • Virginia Beach, Virginia, United States, 23542
      • Sentara Medical Group
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Memorial Hospital, Inc
    • Madison, Wisconsin, United States, 53713
      • Wisconsin Heart-Meriter
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia St. Mary's, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 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.	12 months post-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	Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.	30 days post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure	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).	6 , 12, 24, and 36 months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 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).	6, 24, and 36 months post index procedure
Percentage of Participants With Acute Device and Procedural Success	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.	At time of Index Procedure
Percentage of Participants With Primary Patency at 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.	12 months post-index procedure
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	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).	6, 12, 24, and 36 Months Post Index Procedure
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.	Freedom from major amputation of the target limb defined as above the ankle amputation	6, 12, 24, and 36 Months Post Index Procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Nicholas Shammas, MD, Midwest Cardiovascular Research Foundation; Principal Investigator: Edward Woo, MD, MedStar Regional

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2015
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: BPV-14-006