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

Peripheral Arterial Disease Clinical Trial

— SAFE-DCB  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424383
• Other study ID #: BPV-14-006
• Status: Completed
• Phase: N/A
• Start date: April 23, 2015
• Est. completion date: October 21, 2019

Study information

• Verified date: May 2020
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1005
• Est. completion date: October 21, 2019
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Lake Martin Laser and Vein Institute	Alexander City	Alabama
United States	MedStar Health Research Institute	Annapolis	Maryland
United States	Emory University	Atlanta	Georgia
United States	Northside Hospital, Inc	Atlanta	Georgia
United States	Cardiovascular Specialists of Texas	Austin	Texas
United States	Seton Heart Institute	Austin	Texas
United States	Jane Phillips Memorial Medical Center	Bartlesville	Oklahoma
United States	Lake Washington Vascular, PLLC	Bellevue	Washington
United States	Research Physicians Network Alliance	Boynton Beach	Florida
United States	Bradenton Cardiology Center	Bradenton	Florida
United States	Lankenau Institute for Medical Research	Bryn Mawr	Pennsylvania
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	CAMC Health Education and Research Institute	Charleston	West Virginia
United States	Mercy West Hospital	Cincinnati	Ohio
United States	Clearwater Cardiovascular & Interventional Consultants	Clearwater	Florida
United States	Methodist Health System Clinical Research Institute	Dallas	Texas
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Henry Ford Health System	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	El Paso Cardiology Associates, P.A.	El Paso	Texas
United States	Saint Vincent Consultants in Cardiovascular Diseases	Erie	Pennsylvania
United States	New York Hospital-Queens	Flushing	New York
United States	CaroMont Heart Clinical Research	Gastonia	North Carolina
United States	Stern Cardiovascular Foundation, Inc	Germantown	Tennessee
United States	Bellin Memorial Hospital, Inc	Green Bay	Wisconsin
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey
United States	Heart Institute at Largo	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Merit Health Wesley	Hattiesburg	Mississippi
United States	Kaiser Foundation Hospitals	Honolulu	Hawaii
United States	Houston Methodist Research Institute	Houston	Texas
United States	Hutchinson Regional Medical Center - Hutchinson, Inc	Hutchinson	Kansas
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Sarah Cannon Research Institute, LLC	Jacksonville	Florida
United States	Freeman Health System	Joplin	Missouri
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Wisconsin Heart-Meriter	Madison	Wisconsin
United States	DLP Marquette General Hospital	Marquette	Michigan
United States	Stern Cardiovascular Foundation Inc.	Memphis	Tennessee
United States	Columbia St. Mary's, Inc.	Milwaukee	Wisconsin
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Carolina East Health System	New Bern	North Carolina
United States	Mount Sinai Beth Israel	New York	New York
United States	The Feinstein Institute for Medical Research	New York	New York
United States	Integris Baptist Medical Center, Inc	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Vascular Access Solutions	Orangeburg	South Carolina
United States	Florida Hospital	Orlando	Florida
United States	Orlando Health	Orlando	Florida
United States	Peoria Radiology & Research Foundation	Peoria	Illinois
United States	Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital	Petoskey	Michigan
United States	St. Luke's Hospital- Phoenix	Phoenix	Arizona
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Providence Health & Service	Portland	Oregon
United States	The Miriam Hospital - A Lifespan Partner	Providence	Rhode Island
United States	Rex Hospital, Inc	Raleigh	North Carolina
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	UCSD Health System	San Diego	California
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	The Research Foundation for Suny	Syracuse	New York
United States	Vascular Interventional of Thomasville, Associates	Thomasville	Georgia
United States	Jobst Vascular Institute	Toledo	Ohio
United States	Munson Medical Center	Traverse City	Michigan
United States	Sentara Medical Group	Virginia Beach	Virginia
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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