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
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 Type
OBSERVATIONAL
Enrollment
512
Legflow Drug Coated Balloon
Policlinico di Monza
Monza, Italy
Università Federico II - Dipartimento Scienze Biomediche Avanzate
Napoli, Italy
Policlinico Umberto I
Roma, Italy
Angeles del Carmen
Guadalajara, Mexico
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
Time frame: 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
Time frame: 30 days
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
Time frame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from all cause mortality
all cause mortaliy
Time frame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from CD-TLR
Clinically driven Target Lesion Revascularization
Time frame: 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
Time frame: 6 Months, 12 Months, 24 Months, 36 Months
Freedom from Major target limb amputation
Major target limb amputation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Consulta Privada Cardiovascular Research Institute
Guadalajara, Mexico
Hospital Angeles Mocel
Mexico City, Mexico
Hospital Lopez Mateos
Mexico City, Mexico
Time frame: 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
Time frame: 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).
Time frame: Day 1
Procedural Success
Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time frame: Day 1
Clinical Success
Clinical success is defined as procedural success without in hospital MALE and/or MACCE
Time frame: Day 1