Peripheral Artery DiseaseBTKRegistryNCT02554266
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
An observational study of Peripheral Artery Disease, run by C. R. Bard at 26 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Lutonix 014 Drug Coated Balloon PTA Catheter
- Type of treatment
- Medical device
- How many people
- 371 participants
- Where
- 26 sitesin 11 countries
- Study dates
- 29 Sep 2015to 22 Nov 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- Rutherford Clinical Category 3-5;
- Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
- 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;
- Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
- 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.
Who cannot join
- Patients will be excluded if ANY of the following conditions apply:
- 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);
- Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
- Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
Trial locations and contacts
26 sites in 11 countries.
26 sites in 11 countries
Germany8 sites
Klinikum Hochsauerland
Arnsberg
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, 79189
Universitaetsklinikum Leipzig
Leipzig, 04103
Klinikum Rechts der Isar
Munich, 81675
Marienhospital Osnabrück
Osnabrück
Klinikum Rosenheim
Rosenheim, 83022
MEDINOS Klinik Sonneberg
Sonneberg
Kreiskrankenhaus Viechtach
Viechtach
Austria4 sites
LKH-Univ. Klinikum Graz
Graz, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Medical University Vienna, Department of Angiology
Vienna
Medical University Vienna, Department of Radiodiagnostic
Vienna
Italy3 sites
Clinica Montevergine
Mercogliano
Policlinico di Monza
Monza, 20052
A.O.U. Citta della Salute e della Scienza di Torino
Torino, 10126
Greece2 sites
Attikon University Hospital
Athens
Patras University Hospital
Pátrai, 26504
Switzerland2 sites
University Hospital Basel
Basel, 4031
University Hospital Zurich
Zurich
Saudi Arabia1 site
King Faisal Hospital and Medical research Center
Riyadh, 3354
United Kingdom1 site
University Hospital of South Manchester
Manchester
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Lutonix 014 Drug Coated Balloon PTA Catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix 014 Drug Coated Balloon PTA CatheterDevice
Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse limb related events below the knee and of perioperative death.
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.
Measured: 30-days
Rate of Target Lesion Revascularization (TLR)
Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee.
Measured: 6 months
Secondary outcomes (11)
Primary patency of the target lesion
Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators.
Measured: 6, 12 and 24 months
Freedom from clinically-driven Target Lesion Revascularization (TLR)
All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.
Measured: 12 and 24 months
Rate of amputations above the ankle at the target limb
All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee.
Measured: 1, 6, 12 and 24 months
Rate of Target vessel reintervention (TVR)
All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.
Measured: 1, 6, 12 and 24 months
Rate of unexpected device or drug-related adverse events
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.
Measured: 1, 6, 12 and 24 months
Rate of reintervention for treatment of thrombosis of the target vessel(s)
Arteries may occlude from thrombosis
Measured: 1, 6, 12 and 24 months
Rate of reintervention for embolization to its distal vasculature
Atherothrombotic debris may occlude the artery downstream and cause distal embolization.
Measured: 1, 6, 12 and 24 months
Rate of death
All events leading to a patient's death will be adjudicated by a Clinical Events Committee.
Measured: 1, 6, 12 and 24 months
Status of ischemic wounds at the target limb
Ischemic wounds and their status during the follow-up period will be captured.
Measured: 6 and 12 months
Rate of new or recurrent artery lesions at the target limb
Artery lesions are captured as Adverse Events.
Measured: 6 and 12 months
Change in Rutherford Class at the target limb
The Rutherford class is captured from Baseline to study end.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start29 Sep 2015
- Primary completion31 May 2018
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, Principal investigator, Universitätsklinikum Leipzig: AngiologieMichael Lichtenberg, MD, Principal investigator, Klinikum Arnsberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554266
- Sponsor's protocol ID
- CL0024-01
- Acronym
- BTKRegistry
- Status last verified
- Jan 2019
- First submitted
- 14 Sep 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02554266
- Acronym / sponsor ID
- BTKRegistry / CL0024-01
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- Rutherford Clinical Category 3-5;
- Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
- 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;
- Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
Key exclusion criteria (4 listed)
- 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);
- Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
- Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutonix 014 Drug Coated Balloon PTA CatheterDrug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries | Device | – |
Primary outcome
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.
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.
11 secondary outcomes
Primary patency of the target lesion
Time frame: 6, 12 and 24 months
Freedom from clinically-driven Target Lesion Revascularization (TLR)
Time frame: 12 and 24 months
Rate of amputations above the ankle at the target limb
Time frame: 1, 6, 12 and 24 months
Rate of Target vessel reintervention (TVR)
Time frame: 1, 6, 12 and 24 months
Rate of unexpected device or drug-related adverse events
Time frame: 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
Rate of reintervention for embolization to its distal vasculature
Time frame: 1, 6, 12 and 24 months
Rate of death
Time frame: 1, 6, 12 and 24 months
Status of ischemic wounds at the target limb
Time frame: 6 and 12 months
Rate of new or recurrent artery lesions at the target limb
Time frame: 6 and 12 months
Change in Rutherford Class at the target limb
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dierk Scheinert, MD principal investigator
Universitätsklinikum Leipzig: Angiologie
Michael Lichtenberg, MD principal investigator
Klinikum Arnsberg
26 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by C. R. Bard at 26 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Austria, Italy, Belgium, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse limb related events below the knee and of perioperative death. (time frame: 30-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.