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

January 10, 2020 updated by: C. R. Bard

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Lkh-Univ. Klinikum Graz
      • Klagenfurt am Wörthersee, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
      • Vienna, Austria
        • Medical University Vienna, Department of Angiology
      • Vienna, Austria
        • Medical University Vienna, Department of Radiodiagnostic
  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg
      • Kortrijk, Belgium, 8500
        • AZ groeninghe
  • France
      • Paris, France, 75015
        • Hôpital Européen Georges-Pompidou
  • Germany
      • Arnsberg, Germany
        • Klinikum Hochsauerland
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Munich, Germany, 81675
        • Klinikum rechts der Isar
      • Osnabrück, Germany
        • Marienhospital Osnabrück
      • Rosenheim, Germany, 83022
        • Klinikum Rosenheim
      • Sonneberg, Germany
        • MEDINOS Klinik Sonneberg
      • Viechtach, Germany
        • Kreiskrankenhaus Viechtach
  • Greece
      • Athens, Greece
        • Attikon University Hospital
      • Patra, Greece, 26504
        • Patras University Hospital
  • Italy
      • Mercogliano, Italy
        • Clinica Montevergine
      • Monza, Italy, 20052
        • Policlinico di Monza
      • Torino, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino
  • Portugal
      • Lisboa, Portugal, 1169-1024
        • Hospital Santa Marta (C.H.Lisboa Central)
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3354
        • King Faisal Hospital and Medical research Center
  • Spain
      • Sabadell, Spain, 08208
        • Corporacion Sanitaria Parc Tauli
  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Zurich, Switzerland
        • University Hospital Zurich
  • United Kingdom
      • Manchester, United Kingdom
        • University Hospital of South Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30-days
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6, 12 and 24 months
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.
12 and 24 months
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.
1, 6, 12 and 24 months
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.
1, 6, 12 and 24 months
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.
1, 6, 12 and 24 months
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
1, 6, 12 and 24 months
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.
1, 6, 12 and 24 months
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.
1, 6, 12 and 24 months
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.
6 and 12 months
Rate of new or recurrent artery lesions at the target limb
Time Frame: 6 and 12 months
Artery lesions are captured as Adverse Events.
6 and 12 months
Change in Rutherford Class at the target limb
Time Frame: 6 and 12 months
The Rutherford class is captured from Baseline to study end.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dierk Scheinert, MD, Universitätsklinikum Leipzig: Angiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL0024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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