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

Not Applicable

Completed

Conditions: Peripheral Arterial Disease
Arterial Occlusive Diseases
Peripheral Vascular Diseases

Registration Number: NCT02424383

Lead Sponsor: C. R. Bard

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1005

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure	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.
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	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.

Secondary Outcome Measures

Name	Time	Method
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	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).
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	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).
Percentage of Participants With Acute Device and Procedural Success	At time of Index Procedure	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.
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure	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.
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	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).
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.	6, 12, 24, and 36 Months Post Index Procedure	Freedom from major amputation of the target limb defined as above the ankle amputation

Trial Locations

Locations (72): 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
🇺🇸
Annapolis, Maryland, 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
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Lake Martin Laser and Vein Institute
🇺🇸Alexander City, Alabama, United States