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

Completed

• Conditions: Occluded or stenotic superficial femoral and/or popliteal arteries; Circulatory System; Arterial embolism and thrombosis

• Registration Number: ISRCTN58138617
• Lead Sponsor: Terumo Europe N.V. (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of clinically driven target lesion revascularisation at 6 and 12 months.<br>