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

NCT02424383 | Completed Results

• 1 other identifier: BPV-14-006
• Study Type: interventional
• Target: 1,005
• Locations: 1 country
• Sites: 73

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• 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

• Percentage of Participants With Acute Device and Procedural Success

  At time of Index Procedure

• Percentage of Participants With Primary Patency at 12 Months Post Index Procedure

  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

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

Study Arms (1)

PTA (Lutonix® 035 DCB Catheter)

EXPERIMENTAL

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)

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.

PTA (Lutonix® 035 DCB Catheter)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (73)

Lake Martin Laser and Vein Institute

Alexander City, Alabama, 35010, United States

Location

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

St. Luke's Hospital- Phoenix

Phoenix, Arizona, 85006, United States

Location

UCSD Health System

San Diego, California, 92093, United States

Location

Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Research Physicians Network Alliance

Boynton Beach, Florida, 33435, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

Clearwater Cardiovascular & Interventional Consultants

Clearwater, Florida, 33756, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32207, United States

Location

Sarah Cannon Research Institute, LLC

Jacksonville, Florida, 32216, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northside Hospital, Inc

Atlanta, Georgia, 30342, United States

Location

Vascular Interventional of Thomasville, Associates

Thomasville, Georgia, 31792, United States

Location

Kaiser Foundation Hospitals

Honolulu, Hawaii, 96819, United States

Location

Peoria Radiology & Research Foundation

Peoria, Illinois, 61637, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Hutchinson Regional Medical Center - Hutchinson, Inc

Hutchinson, Kansas, 67502, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

MedStar Health Research Institute

Annapolis, Maryland, 21401, United States

Location

Cape Cod Research Institute

Hyannis, Massachusetts, 02601, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

DLP Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

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

Petoskey, Michigan, 49770, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Merit Health Wesley

Hattiesburg, Mississippi, 39402, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

New York Hospital-Queens

Flushing, New York, 11355, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

The Feinstein Institute for Medical Research

New York, New York, 10075, United States

Location

The Research Foundation for Suny

Syracuse, New York, 13210, United States

Location

CaroMont Heart Clinical Research

Gastonia, North Carolina, 28054, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Carolina East Health System

New Bern, North Carolina, 28562, United States

Location

Rex Hospital, Inc

Raleigh, North Carolina, 27607, United States

Location

Mercy West Hospital

Cincinnati, Ohio, 45211, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43603, United States

Location

Jane Phillips Memorial Medical Center

Bartlesville, Oklahoma, 74006, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Integris Baptist Medical Center, Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Health & Service

Portland, Oregon, 97225, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19010, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Heart Institute at Largo

Harrisburg, Pennsylvania, 17110, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

The Miriam Hospital - A Lifespan Partner

Providence, Rhode Island, 02906, United States

Location

Vascular Access Solutions

Orangeburg, South Carolina, 29118, United States

Location

Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, 38138, United States

Location

Stern Cardiovascular Foundation Inc.

Memphis, Tennessee, 38120, United States

Location

Seton Heart Institute

Austin, Texas, 78705, United States

Location

Cardiovascular Specialists of Texas

Austin, Texas, 78758, United States

Location

Methodist Health System Clinical Research Institute

Dallas, Texas, 75203, United States

Location

El Paso Cardiology Associates, P.A.

El Paso, Texas, 79902, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23225, United States

Location

Sentara Medical Group

Virginia Beach, Virginia, 23542, United States

Location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

CAMC Health Education and Research Institute

Charleston, West Virginia, 25304, United States

Location

Bellin Memorial Hospital, Inc

Green Bay, Wisconsin, 54301, United States

Location

Wisconsin Heart-Meriter

Madison, Wisconsin, 53713, United States

Location

Columbia St. Mary's, Inc.

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sharon Christensen
• Organization: Becton Dickinson

Sharon.Christensen@bd.com

612-757-0750

Study Officials

• Nicholas Shammas, MD

  Midwest Cardiovascular Research Foundation

  PRINCIPAL INVESTIGATOR

• Edward Woo, MD

  MedStar Regional

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 23, 2015
• Study Start: April 23, 2015
• Primary Completion: October 27, 2017
• Study Completion: October 21, 2019
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Locations

US (73)