Status:
COMPLETED
Lutonix Global SFA Registry
Lead Sponsor:
C. R. Bard
Collaborating Sponsors:
Bard Ltd
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the L...
Eligibility Criteria
Inclusion
- Male or non-pregnant female ≥18 years of age;
- Rutherford Clinical Category ≤ 4;
- Patient is willing to provide 5-year informed consent and comply with the required follow up;
- Stenotic or obstructive vascular lesions of the femoropopliteal artery;
- Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
- 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).
Exclusion
- Patient is currently participating in an investigational drug or device study;
- Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
- Pregnant or planning on becoming pregnant or men intending to father a child;
- Rutherford Class \> 4
- Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
691 Patients enrolled
Trial Details
Trial ID
NCT01864278
Start Date
December 1 2012
End Date
September 1 2016
Last Update
November 8 2016
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
2
ZNA Campus Middelheim
Antwerp, Belgium, 2020
3
CHU Le Bocage
Dijon, France, 21079
4
Karolinen Hospital Huesten
Arnsberg, Germany, 59759