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Peripheral Arterial DiseaseSAFE-DCBNCT02424383

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

A study testing PTA (Lutonix® 035 DCB Catheter) in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by C. R. Bard at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
PTA (Lutonix® 035 DCB Catheter)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,005 participants
Where
73 sitesUnited States
Study dates
23 Apr 2015to 21 Oct 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Lake Martin Laser and Vein Institute

    Alexander City, Alabama, 35010

  • MedStar Health Research Institute

    Annapolis, Maryland, 21401

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital, Inc

    Atlanta, Georgia, 30342

  • Seton Heart Institute

    Austin, Texas, 78705

  • Cardiovascular Specialists of Texas

    Austin, Texas, 78758

  • Jane Phillips Memorial Medical Center

    Bartlesville, Oklahoma, 74006

  • Lake Washington Vascular, PLLC

    Bellevue, Washington, 98004

  • Research Physicians Network Alliance

    Boynton Beach, Florida, 33435

  • Bradenton Cardiology Center

    Bradenton, Florida, 34205

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19010

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • CAMC Health Education and Research Institute

    Charleston, West Virginia, 25304

  • Mercy West Hospital

    Cincinnati, Ohio, 45211

  • Clearwater Cardiovascular & Interventional Consultants

    Clearwater, Florida, 33756

  • Methodist Health System Clinical Research Institute

    Dallas, Texas, 75203

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • El Paso Cardiology Associates, P.A.

    El Paso, Texas, 79902

  • Saint Vincent Consultants in Cardiovascular Diseases

    Erie, Pennsylvania, 16502

  • New York Hospital-Queens

    Flushing, New York, 11355

  • CaroMont Heart Clinical Research

    Gastonia, North Carolina, 28054

  • Stern Cardiovascular Foundation, Inc

    Germantown, Tennessee, 38138

  • Bellin Memorial Hospital, Inc

    Green Bay, Wisconsin, 54301

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Heart Institute at Largo

    Harrisburg, Pennsylvania, 17110

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Merit Health Wesley

    Hattiesburg, Mississippi, 39402

  • Kaiser Foundation Hospitals

    Honolulu, Hawaii, 96819

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Hutchinson Regional Medical Center - Hutchinson, Inc

    Hutchinson, Kansas, 67502

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32207

  • Sarah Cannon Research Institute, LLC

    Jacksonville, Florida, 32216

  • Freeman Health System

    Joplin, Missouri, 64804

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Wisconsin Heart-Meriter

    Madison, Wisconsin, 53713

  • DLP Marquette General Hospital

    Marquette, Michigan, 49855

  • Stern Cardiovascular Foundation Inc.

    Memphis, Tennessee, 38120

  • Columbia St. Mary's, Inc.

    Milwaukee, Wisconsin, 53211

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Carolina East Health System

    New Bern, North Carolina, 28562

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • The Feinstein Institute for Medical Research

    New York, New York, 10075

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Integris Baptist Medical Center, Inc

    Oklahoma City, Oklahoma, 73112

  • Vascular Access Solutions

    Orangeburg, South Carolina, 29118

  • Florida Hospital

    Orlando, Florida, 32803

  • Orlando Health

    Orlando, Florida, 32806

  • Peoria Radiology & Research Foundation

    Peoria, Illinois, 61637

  • Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • St. Luke's Hospital- Phoenix

    Phoenix, Arizona, 85006

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Health & Service

    Portland, Oregon, 97225

  • The Miriam Hospital - A Lifespan Partner

    Providence, Rhode Island, 02906

  • Rex Hospital, Inc

    Raleigh, North Carolina, 27607

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23225

  • UCSD Health System

    San Diego, California, 92093

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • The Research Foundation for Suny

    Syracuse, New York, 13210

  • Vascular Interventional of Thomasville, Associates

    Thomasville, Georgia, 31792

  • Jobst Vascular Institute

    Toledo, Ohio, 43603

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Sentara Medical Group

    Virginia Beach, Virginia, 23542

  • MedStar Health Research Institute

    Washington D.C., District of Columbia, 20010

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
PTA (Lutonix® 035 DCB Catheter)
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02424383
Study groupRoleWhat they receive
PTA (Lutonix® 035 DCB Catheter)ExperimentalTreatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
Receives: Device: PTA (Lutonix® 035 DCB Catheter)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-index procedure

  2. 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.

    Measured: 30 days post index procedure

Secondary outcomes (6)

  1. 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).

    Measured: 6 , 12, 24, and 36 months

  2. 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).

    Measured: 6, 24, and 36 months post index procedure

  3. 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.

    Measured: At time of Index Procedure

  4. 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.

    Measured: 12 months post-index procedure

  5. 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).

    Measured: 6, 12, 24, and 36 Months Post Index Procedure

  6. 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

    Measured: 6, 12, 24, and 36 Months Post Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study start23 Apr 2015
  3. Primary completion27 Oct 2017
  4. Study completion21 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424383
Sponsor's protocol ID
BPV-14-006
Acronym
SAFE-DCB
Status last verified
May 2020
First submitted
20 Apr 2015
Last updated
22 May 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing PTA (Lutonix® 035 DCB Catheter) in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by C. R. Bard at 73 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure (time frame: 12 months post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.

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