Recruitment

Recruitment Status
Completed
Estimated Enrollment
1000

Inclusion Criterias

Male or non-pregnant female ≥18 years of age;
At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
Patient is willing to provide 5-year informed consent and comply with the required follow up;
...
Male or non-pregnant female ≥18 years of age;
At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
Patient is willing to provide 5-year informed consent and comply with the required follow up;
Rutherford Clinical Category ≤ 4;
Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
Stenotic or obstructive vascular lesions of the femoropopliteal artery;

Exclusion Criterias

Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Pregnant or planning on becoming pregnant or men intending to father a child;
Patient is currently participating in an investigational drug or device study;
...
Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Pregnant or planning on becoming pregnant or men intending to father a child;
Patient is currently participating in an investigational drug or device study;
Rutherford Class > 4
Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;

Summary

Conditions
Peripheral Artery Disease
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Male or non-pregnant female ≥18 years of age;
At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
Patient is willing to provide 5-year informed consent and comply with the required follow up;
...
Male or non-pregnant female ≥18 years of age;
At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
Patient is willing to provide 5-year informed consent and comply with the required follow up;
Rutherford Clinical Category ≤ 4;
Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
Stenotic or obstructive vascular lesions of the femoropopliteal artery;

Exclusion Criterias

Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Pregnant or planning on becoming pregnant or men intending to father a child;
Patient is currently participating in an investigational drug or device study;
...
Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Pregnant or planning on becoming pregnant or men intending to father a child;
Patient is currently participating in an investigational drug or device study;
Rutherford Class > 4
Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;

Locations

Poznan, 61-848
Aarau, 5001
Barcelona, 08036
Asti, 14100
Dijon, 21079
...
Poznan, 61-848
Aarau, 5001
Barcelona, 08036
Asti, 14100
Dijon, 21079
Sondalo, 23035
Torun, 87-100
London, SE1 7EH
Muenchen, 80331
Manchester, M23 9LT
Torino
Antwerp, 2020
Arnsberg, 59759
Sonneberg, 96515
Liverpool, L7 8XP
San Donato Milanese, 20097
Bydgoszcz, 85-168
Manchester, M13 9WL
Patras, 26504
Viechtach, 94234
Vienna, 1090
Newcastle upon Tyne, WE7 7DN
Weiden, 92637

Tracking Information

NCT #
NCT01864278
Collaborators
Bard Ltd
Investigators
Not Provided