Peripheral Arterial DiseaseLEGDEB2NCT04175197
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Federico II University at 7 sites in 2 countries.
Trial summary
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
- What is being tested?
- Drug Coated Balloon
- Type of treatment
- Medical device
- How many people
- 512 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2019to Dec 2024
- 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: Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee iliac arterial occlusion or stenosis will be consecutively screened and enrolled based on the study inclusion and exclusion criteria.
Who may be able to join
- Age ≥ 18 years or minimum age as required by local regulations.
- Subject with documented diagnosis of lower extremities arterial disease (LEAD).
- Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
- Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
- Adequate distal run-off to the ankle (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
- Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment.
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- Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment.
- Signed and dated Patient Informed Consent (PIC) form.
- Ability and willingness to comply with the clinical investigation plan (CIP).
- Life expectancy, in the Investigator's opinion, of at least 12 months
Who cannot join
- High probability of non-adherence to CIP follow-up requirements.
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
- Acute or sub-acute thrombus in the target vessel.
- Target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy).
- Plan for surgical or interventional procedure within 30 days after the study procedure (except for bilateral target limb treatment).
- Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Mexico4 sites
Angeles del Carmen
Guadalajara
Gustavo Rubio, MD
Consulta Privada Cardiovascular Research Institute
Guadalajara
Luis Virgen, MD
Hospital Angeles Mocel
Mexico City
Alfonso Espinosa, MD
Hospital Lopez Mateos
Mexico City
Jorge Torres, MD
Italy3 sites
Policlinico di Monza
Monza
Giovanni Sorropago, MD
Università Federico II - Dipartimento Scienze Biomediche Avanzate
Naples
Eugenio Stabile, Prof., eugenio.stabile@unina.it
Policlinico Umberto I
Roma
Francesco Speziale, Prof.
Francesco Speziale, Prof
About this study
Official title: The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
Read the detailed description
LEGDEB2 is a Global Registry aimed to prospectively collect and assess global safety and efficacy data on the Legflow Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in "real world" patient population.
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases, Popliteal Artery Stenosis, Critical Limb Ischemia
- Being tested
- Drug Coated Balloon
- Keywords
- Stenosis, Drug Coated Balloon, Paclitaxel, Artery Disease
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Chronic Limb-Threatening Ischemia, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Coated BalloonDevice
Legflow Drug Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee arterial occlusion or stenosis Receives: Device: Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Freedom from Clinically driven TLR
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as:
- Any re-intervention within the target lesion(s) due to symptoms
Measured: 12 Months
Safety: Freedom from MAE
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from device or procedure related mortality, freedom from any cardiac or cardiovascular death, freedom from major target limb amputation
Measured: 30 days
Secondary outcomes (9)
Freedom from MALE and MACCE
MALE is defined as acute limb ischemia, urgent revascularization or mayor amputation of the treated limb MACCE is defined as Death, Acute myocardial infarction or stroke
Measured: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from all cause mortality
all cause mortaliy
Measured: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from CD-TLR
Clinically driven Target Lesion Revascularization
Measured: 24 Months, 36 Months
Freedom from CD-TVR
Clinically driven Target Vessel Revascularization Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms
Measured: 6 Months, 12 Months, 24 Months, 36 Months
Freedom from Major target limb amputation
Major target limb amputation
Measured: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Primary sustained clinical improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Measured: 6 Months, 12 Months, 24 Months, 36 Months
Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Measured: Day 1
Procedural Success
Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Measured: Day 1
Clinical Success
Clinical success is defined as procedural success without in hospital MALE and/or MACCE
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenio Stabile, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175197
- Sponsor's protocol ID
- LEGDEB2 v.3.1
- Acronym
- LEGDEB2
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stabile E, Gerardi D, Magliulo F, Zhelev D, Chervenkoff V, Taeymans K, Kotasov D, Goverde P, Giugliano G, Trimarco B, Esposito G. One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry. J Endovasc Ther. 2019 Feb;26(1):26-30. doi: 10.1177/1526602818823557.
PubMed 30760132
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon
- ClinicalTrials.gov ID
- NCT04175197
- Acronym / sponsor ID
- LEGDEB2 / LEGDEB2 v.3.1
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases, Popliteal Artery Stenosis, Critical Limb Ischemia
- Keywords
- Stenosis, Drug Coated Balloon, Paclitaxel, Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Nov 2019 (actual)
- 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.
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
Detailed description
LEGDEB2 is a Global Registry aimed to prospectively collect and assess global safety and efficacy data on the Legflow Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in "real world" patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: Drug Coated BalloonSubjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee arterial occlusion or stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee iliac arterial occlusion or stenosis will be consecutively screened and enrolled based on the study inclusion and exclusion criteria.
Key inclusion criteria (10 listed)
- Age ≥ 18 years or minimum age as required by local regulations.
- Subject with documented diagnosis of lower extremities arterial disease (LEAD).
- Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
- Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
- Adequate distal run-off to the ankle (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
Key exclusion criteria (7 listed)
- High probability of non-adherence to CIP follow-up requirements.
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
- Acute or sub-acute thrombus in the target vessel.
- Target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy).
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 |
|---|---|---|
| Drug Coated BalloonLegflow Drug Coated Balloon | Device | Study Cohort |
Primary outcome
Efficacy: Freedom from Clinically driven TLR
Time frame: 12 Months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: * Any re-intervention within the target lesion(s) due to symptoms
Safety: Freedom from MAE
Time frame: 30 days
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from device or procedure related mortality, freedom from any cardiac or cardiovascular death, freedom from major target limb amputation
9 secondary outcomes
Freedom from MALE and MACCE
Time frame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from all cause mortality
Time frame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from CD-TLR
Time frame: 24 Months, 36 Months
Freedom from CD-TVR
Time frame: 6 Months, 12 Months, 24 Months, 36 Months
Freedom from Major target limb amputation
Time frame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Primary sustained clinical improvement
Time frame: 6 Months, 12 Months, 24 Months, 36 Months
Device Success
Time frame: Day 1
Procedural Success
Time frame: Day 1
Clinical Success
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Results publication: PubMed 30760132Stabile E, Gerardi D, Magliulo F, Zhelev D, Chervenkoff V, Taeymans K, Kotasov D, Goverde P, Giugliano G, Trimarco B, Esposito G. One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry. J Endovasc Ther. 2019 Feb;26(1):26-30. doi: 10.1177/1526602818823557.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Federico II University at 7 sites in 2 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Mexico, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenio Stabile, Prof. (+39 081 7462239, eugenio.stabile@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Freedom from Clinically driven TLR (time frame: 12 Months). 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?
On the ClinicalTrials.gov record for NCT04175197, which also lists 1 linked publication.
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 22 Nov 2019.