Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
Abstract
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 artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
Conditions: Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment, Quality of Life Scores at 12 and 24 Months.
Primary outcome: Improvement in Quality of Life scores.
Enrollment: 100 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 100 participants or records.
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