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Completed

NCT Number: NCT02424383

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lake Martin Laser and Vein Institute, Alexander City, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. 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

    Time frame: 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 outcomes

  1. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure

    Time frame: 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).

  2. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.

    Time frame: 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).

  3. Percentage of Participants With Acute Device and Procedural Success

    Time frame: 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.

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

    Time frame: 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.

  5. 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

    Time frame: 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. 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.

    Time frame: 6, 12, 24, and 36 Months Post Index Procedure

    Freedom from major amputation of the target limb defined as above the ankle amputation

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study 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)

Acronym: SAFE-DCB

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Apr 23, 2015
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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