Comparison of Supera and Absolute Pro stent systems for femoro-popliteal lesions; a feasibility study

Completed

Conditions: intermittent claudication
peripheral arterial disease
10003216

Registration Number: NL-OMON42369

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- PAD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
- Significant stenoses (* 50%) and/or occlusions in the superficial femoral artery and/or popliteal artery (P1)
- Eligible for endovascular treatment according to international guidelines (with the expectation of stenting after PTA)
- Adequate inflow (<50% stenosis) either pre-existing or successfully re-established prior to target lesion treatment without complications (e.g. embolization, thrombotic event, perforation, etc.)
- Age * 18

Exclusion Criteria

- Patients with PAD Rutherford category 5 and 6
- Contralateral lesions that require treatment within 30 days before or after the procedure
- Contra-indication for anticoagulant therapy
- Life expectancy < 1 year
- Known contrast allergy
- Pregnancy
- Unable to complete a questionnaire in the home language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Absence of binary restenosis (* 50% re-obstruction) of the target lesion as<br /><br>assessed by duplex ultrasound after 12 months without interval clinically<br /><br>driven reintervention<br /><br>- Number of clinically driven target lesion revascularisation within 12 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes in pain-free walking distance and absolute walking distance as<br /><br>assessed by standardized exercise test<br /><br>- Changes in quality of life as assessed by EuroQol 5 Demension (EQ-5D)<br /><br>questionnaire<br /><br>- Clinical complications (number of adverse events, serious adverse events and<br /><br>major adverse events)<br /><br>- Sustained clinical improvement as assessed by distribution of Rutherford<br /><br>stages<br /><br>- Procedural success (technical success, device success and procedural<br /><br>complications)</p><br>