Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    lutonix 014
Previous Study | Return to List | Next Study

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries (BTKRegistry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02554266
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Condition or disease Intervention/treatment
Peripheral Artery Disease Device: Lutonix 014 Drug Coated Balloon PTA Catheter

Detailed Description:
Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 371 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries
Actual Study Start Date : September 29, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : November 22, 2019

Intervention Details:
  • Device: Lutonix 014 Drug Coated Balloon PTA Catheter
    Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries


Primary Outcome Measures :
  1. Freedom from major adverse limb related events below the knee and of perioperative death. [ Time Frame: 30-days ]
    Freedom from the composite of all-cause death, above-ankle amputation or major reintervention, i.e. new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis, of the index limb involving a below-the-knee artery. All these events will be adjudicated by a Clinical Events Committee.

  2. Rate of Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee.


Secondary Outcome Measures :
  1. Primary patency of the target lesion [ Time Frame: 6, 12 and 24 months ]
    Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators.

  2. Freedom from clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 12 and 24 months ]
    All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.

  3. Rate of amputations above the ankle at the target limb [ Time Frame: 1, 6, 12 and 24 months ]
    All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee.

  4. Rate of Target vessel reintervention (TVR) [ Time Frame: 1, 6, 12 and 24 months ]
    All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.

  5. Rate of unexpected device or drug-related adverse events [ Time Frame: 1, 6, 12 and 24 months ]
    Unexpected device or drug-related adverse events are those events that are related to the device or drug, but are not listed in the potential adverse event section of the Instructions For Use.

  6. Rate of reintervention for treatment of thrombosis of the target vessel(s) [ Time Frame: 1, 6, 12 and 24 months ]
    Arteries may occlude from thrombosis

  7. Rate of reintervention for embolization to its distal vasculature [ Time Frame: 1, 6, 12 and 24 months ]
    Atherothrombotic debris may occlude the artery downstream and cause distal embolization.

  8. Rate of death [ Time Frame: 1, 6, 12 and 24 months ]
    All events leading to a patient's death will be adjudicated by a Clinical Events Committee.

  9. Status of ischemic wounds at the target limb [ Time Frame: 6 and 12 months ]
    Ischemic wounds and their status during the follow-up period will be captured.

  10. Rate of new or recurrent artery lesions at the target limb [ Time Frame: 6 and 12 months ]
    Artery lesions are captured as Adverse Events.

  11. Change in Rutherford Class at the target limb [ Time Frame: 6 and 12 months ]
    The Rutherford class is captured from Baseline to study end.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee.
Criteria

Inclusion Criteria:

  1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
  2. Rutherford Clinical Category 3-5;
  3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
  4. Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
  5. Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
  6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).

NOTE: Outflow must be assessed AFTER pre-dilatation NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

  1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
  2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
  3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554266


Locations
Show Show 26 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
Layout table for investigator information
Principal Investigator: Dierk Scheinert, MD Universitätsklinikum Leipzig: Angiologie
Principal Investigator: Michael Lichtenberg, MD Klinikum Arnsberg
Additional Information:

Layout table for additonal information
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02554266    
Other Study ID Numbers: CL0024-01
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases