Clinical trial NCT02424383: Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 1005
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
timeFrame: 12 months post-index procedure
measure: 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
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
timeFrame: 6 , 12, 24, and 36 months
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
timeFrame: 6, 24, and 36 months post index procedure
measure: Percentage of Participants With Acute Device and Procedural Success
timeFrame: At time of Index Procedure
measure: Percentage of Participants With Primary Patency at 12 Months Post Index Procedure
timeFrame: 12 months post-index procedure
measure: 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
timeFrame: 6, 12, 24, and 36 Months Post Index Procedure
measure: 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.
timeFrame: 6, 12, 24, and 36 Months Post Index Procedure
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Lake Martin Laser and Vein Institute
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Luke's Hospital- Phoenix
state: Arizona
city: San Diego
country: United States
facility: UCSD Health System
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Boynton Beach
country: United States
facility: Research Physicians Network Alliance
state: Florida
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Sarah Cannon Research Institute, LLC
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital, Inc
state: Georgia
city: Thomasville
country: United States
facility: Vascular Interventional of Thomasville, Associates
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Foundation Hospitals
state: Hawaii
city: Peoria
country: United States
facility: Peoria Radiology & Research Foundation
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Hutchinson
country: United States
facility: Hutchinson Regional Medical Center - Hutchinson, Inc
state: Kansas
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Annapolis
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Marquette
country: United States
facility: DLP Marquette General Hospital
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Hattiesburg
country: United States
facility: Merit Health Wesley
state: Mississippi
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Flushing
country: United States
facility: New York Hospital-Queens
state: New York
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: Syracuse
country: United States
facility: The Research Foundation for Suny
state: New York
city: Gastonia
country: United States
facility: CaroMont Heart Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: New Bern
country: United States
facility: Carolina East Health System
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: Mercy West Hospital
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Bartlesville
country: United States
facility: Jane Phillips Memorial Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center, Inc
state: Oklahoma
city: Portland
country: United States
facility: Providence Health & Service
state: Oregon
city: Bryn Mawr
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Harrisburg
country: United States
facility: Heart Institute at Largo
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital - A Lifespan Partner
state: Rhode Island
city: Orangeburg
country: United States
facility: Vascular Access Solutions
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc
state: Tennessee
city: Memphis
country: United States
facility: Stern Cardiovascular Foundation Inc.
state: Tennessee
city: Austin
country: United States
facility: Seton Heart Institute
state: Texas
city: Austin
country: United States
facility: Cardiovascular Specialists of Texas
state: Texas
city: Dallas
country: United States
facility: Methodist Health System Clinical Research Institute
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates, P.A.
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Medical Group
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute
state: West Virginia
city: Green Bay
country: United States
facility: Bellin Memorial Hospital, Inc
state: Wisconsin
city: Madison
country: United States
facility: Wisconsin Heart-Meriter
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's, Inc.
state: Wisconsin
Study officials:
affiliation: Midwest Cardiovascular Research Foundation
name: Nicholas Shammas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedStar Regional
name: Edward Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: