ISRCTN58138617
Completed
Not Applicable
Prospective, non-randomised, multi-centre, observational study to confirm the performance of Misago® peripheral self-expanding stent system for the treatment of occluded or stenotic superficial femoral or popliteal arteries
Terumo Europe N.V. (Belgium)0 sites500 target enrollmentJune 5, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Occluded or stenotic superficial femoral and/or popliteal arteries
- Sponsor
- Terumo Europe N.V. (Belgium)
- Enrollment
- 500
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must fulfil all of the following criteria:
- •1\. Patients with symptomatic one or two legs ischaemia, requiring treatment of superficial femoral artery (SFA) or popliteal artery (two or more by Rutherford classification)
- •2\. Single lesions per leg with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion, which can be covered by maximum two stents
- •3\. Target vessel reference diameter greater than or equal to 4 mm and less than or equal to 6 mm (by visual estimate)
- •4\. Target lesion length should consider that maximum two Misago® stents can be implanted per lesion with recommended overlap of 2 mm
- •5\. At least one patent (less than 50% stenosis) tibioperoneal run\-off vessel confirmed by baseline angiography
- •6\. Patient is suitable candidate for femoral\-popliteal artery bypass surgery
- •7\. Aged 18 years or older, either sex
Exclusion Criteria
- •Patients with any of the following should be excluded:
- •1\. Pregnancy
- •2\. Previous bypass surgery or stenting in the target vessel
- •3\. Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure
- •4\. Co\-existing aneurismal disease of the abdominal aorta, iliac or popliteal arteries
- •5\. Acute thrombophlebitis or deep venous thrombosis
- •6\. Haemodynamic instability
- •7\. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
- •8\. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti\-platelet therapy
- •9\. Known intolerance to study medications, contrast agents or nitinol
Outcomes
Primary Outcomes
Not specified
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