Status:
COMPLETED
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
Lead Sponsor:
Lund University
Conditions:
Stable Claudication (Fontaine IIa and IIb)
Superficial Femoral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral arter...
Detailed Description
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene. Treatment options inclu...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study.
- Patient suffering from stable claudication (Fontaine IIa and IIb).
- One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA.
- Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA.
- Patient is willing and able to comply with the specified follow-up evaluation
- The patient or legally authorized representative must provide written informed consent prior to the procedure.
Exclusion
- Recent hemorrhagic stroke (within past 3 months)
- Aneurysm in the SFA or popliteal artery
- Previously implanted stent(s) in the to be treated artery at the same site
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
- Revascularisation involving the same limb 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure
- Critical Limb Ischemia in the index leg (Fontaine III and IV). 9.Requirement of stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
- Life expectancy of less than 24 months or other factors making clinical follow-up difficult 11.Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of principal investigator of this study.
- Walking capacity more than 500 meters.
- \-
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01230229
Start Date
January 1 2010
End Date
August 1 2017
Last Update
August 23 2017
Active Locations (2)
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1
Dept of Radiology, Helsingborg Hospital
Helsingborg, Sweden, S-251 87
2
Department of Vascular Disease, Skåne University Hospital
Malmo, Sweden, S-205 02