Supervised Exercise Therapy or Endovascular Revascularization for Intermittent Claudication due to an iliac artery obstruction. - SUPER-study

Academisch Medisch Centrum0 个研究点目标入组 400 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Age >= 18 years
•- Disabling claudication as defined by surgeon based on patient history.
•- Ankle/Brachial Index < 0.9 or drop in ABI > 0.15 after exercise test.
•- Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA (> 50% stenosis) or occlusion of the common or external iliac artery on Color Duplex Scanning (PSV 0 m/s) or on MRA
•- Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis > 50% by Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA, or occlusion on DS (PSV 0 m/s) or MRA.
•- Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions.
•- Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline
•- The Maximum Walking Distance on a treadmill < 300 meters

•- Life expectancy < 3 months
•- Unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
•- Known contrast allergy
•- Pregnancy
•- Contra-indication for anticoagulant therapy
•- Duration of current complaints < 3 months
•- Occlusion of the common femoral artery at the affected side
•- Patient participates in another study
•- Heart failure or Angina Pectoris NYHA III or IV.
•(NYHA III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea
•NYHA IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased)
•- Patient previously received SET according to KNGF guidelines
•- Renal insufficiency (serum creatinin > 150 micromol/l)

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