This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Balloon angioplasty. Only stent if PTA fails
Nitinol stent
Universtiy of Tuebingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGMLD at the target lesion assessed by angiography
treatment effect dependent if stent of PTA was choosen
Time frame: after 12 +/-2 months
1. Interventional success rate. Interventional success is defined as restenosis less than 50%. 2. Late lumen loss (LLL)
treatment effect dependent on the PTA vs. Stent
Time frame: after 1, 6, 12 months and 3 years
3. Binary restenosis
Treament effect in long-term
Time frame: arter 6, 12 months and 3 years
4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success.
success rate of PTA only
Time frame: intervention
Target lesion revascularization, clinical stage, hospital days
treatment effect dependet if patients received stents or PTA only
Time frame: after 1, 6, 12 months, and 3 years
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