Prospective, Non-randomized, Multicentre, Observational Registry To confirm the performance of Misago Peripheral Self-Expanding Stent System for the Treatment of Occluded or Stenotic Superficial Femoral or Popliteal Arteries.
- Conditions
- blockage of arteriesocclusionstenosis10003216
- Registration Number
- NL-OMON32020
- Lead Sponsor
- Terumo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Patients with documented symptomatic occlusion and/or >70%
stenosis of SFA or popliteal artery in one or both legs;1. Patients with symptomatic one or two legs ischemia, requiring
treatment of SFA or popliteal artery (2 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 >=4mm and <=6mm (by visual
estimate)
4. Target lesion length should consider that maximum two Misago
stents can be implanted per lesion with recommended overlap 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
Patient 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. Hemodynamic instability
7. Untreated inflow disease of the ipsilateral pelvic arteries (more
than 50 percent stenosis or occlusion),
8. Significant gastrointestinal bleeding or any coagulopathy that
would contraindicate the use of anti-platelet therapy
9. Known
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Absence of clinically driven target lesion revascularization at 6 and 12 months</p><br>
- Secondary Outcome Measures
Name Time Method