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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04175197
Other study ID # LEGDEB2 v.3.1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2019
Est. completion date December 2024

Study information

Verified date November 2019
Source Federico II University
Contact Eugenio Stabile, Prof.
Phone +39 081 7462239
Email eugenio.stabile@unina.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 512
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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.

- 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

Exclusion Criteria:

- 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.

Study Design


Intervention

Device:
Drug Coated Balloon
Legflow Drug Coated Balloon

Locations

Country Name City State
Italy Policlinico di Monza Monza
Italy Università Federico II - Dipartimento Scienze Biomediche Avanzate Napoli
Italy Policlinico Umberto I Roma
Mexico Hospital Angeles Mocel Ciudad de Mexico
Mexico Hospital Lopez Mateos Ciudad de Mexico
Mexico Angeles del Carmen Guadalajara
Mexico Consulta Privada Cardiovascular Research Institute Guadalajara

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Countries where clinical trial is conducted

Italy,  Mexico, 

References & Publications (1)

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 End — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
12 Months
Primary 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 30 days
Secondary 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 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Secondary Freedom from all cause mortality all cause mortaliy 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Secondary Freedom from CD-TLR Clinically driven Target Lesion Revascularization 24 Months, 36 Months
Secondary 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 6 Months, 12 Months, 24 Months, 36 Months
Secondary Freedom from Major target limb amputation Major target limb amputation 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Secondary 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 6 Months, 12 Months, 24 Months, 36 Months
Secondary 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). Day 1
Secondary Procedural Success Procedural success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate Day 1
Secondary Clinical Success Clinical success is defined as procedural success without in hospital MALE and/or MACCE Day 1
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