Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
NCT ID: NCT02424383
Last Updated: 2020-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1005 participants
INTERVENTIONAL
2015-04-23
2019-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Shammas, MD
Role: PRINCIPAL_INVESTIGATOR
Midwest Cardiovascular Research Foundation
Edward Woo, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Regional
Locations
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Lake Martin Laser and Vein Institute
Alexander City, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
St. Luke's Hospital- Phoenix
Phoenix, Arizona, United States
UCSD Health System
San Diego, California, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Research Physicians Network Alliance
Boynton Beach, Florida, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Clearwater Cardiovascular & Interventional Consultants
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Sarah Cannon Research Institute, LLC
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Orlando Health
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital, Inc
Atlanta, Georgia, United States
Vascular Interventional of Thomasville, Associates
Thomasville, Georgia, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, United States
Peoria Radiology & Research Foundation
Peoria, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Hutchinson Regional Medical Center - Hutchinson, Inc
Hutchinson, Kansas, United States
Maine Medical Center
Portland, Maine, United States
MedStar Health Research Institute
Annapolis, Maryland, United States
Cape Cod Research Institute
Hyannis, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
DLP Marquette General Hospital
Marquette, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
Petoskey, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Merit Health Wesley
Hattiesburg, Mississippi, United States
Freeman Health System
Joplin, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 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
The Research Foundation for Suny
Syracuse, New York, United States
CaroMont Heart Clinical Research
Gastonia, North Carolina, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Carolina East Health System
New Bern, North Carolina, United States
Rex Hospital, Inc
Raleigh, North Carolina, United States
Mercy West Hospital
Cincinnati, Ohio, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Jane Phillips Memorial Medical Center
Bartlesville, Oklahoma, 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
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
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
The Miriam Hospital - A Lifespan Partner
Providence, Rhode Island, United States
Vascular Access Solutions
Orangeburg, South Carolina, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States
Stern Cardiovascular Foundation Inc.
Memphis, Tennessee, United States
Seton Heart Institute
Austin, Texas, United States
Cardiovascular Specialists of Texas
Austin, Texas, United States
Methodist Health System Clinical Research Institute
Dallas, Texas, United States
El Paso Cardiology Associates, P.A.
El Paso, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Sentara Medical Group
Virginia Beach, Virginia, United States
Lake Washington Vascular, PLLC
Bellevue, Washington, United States
CAMC Health Education and Research Institute
Charleston, West Virginia, United States
Bellin Memorial Hospital, Inc
Green Bay, Wisconsin, United States
Wisconsin Heart-Meriter
Madison, Wisconsin, United States
Columbia St. Mary's, Inc.
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BPV-14-006
Identifier Type: -
Identifier Source: org_study_id
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