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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02424383
Other study ID # BPV-14-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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