Status:
COMPLETED
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
Lead Sponsor:
be Medical
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Ziekenhuis Oost-Limburg
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
- TASC II (2007)type A, B or C lesions
- Target vessel diameter between 4.5 and 7 mm
- Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- At least 1 outflow vessel down to the ankle
- Patient is at least 18 years old
- Life expectancy \> 2 years
- Patient is compliant with the requested follow-up visits
Exclusion
- No informed consent
- Rutherford 6
- TASC II type D lesions
- Patient is not 18 years old
- Patient is pregnant
- Acute ischemia
- Patient is not compliant with the requested follow-up visits
- Unable to cross target lesion with guidewire
- Patient is allergic to nickel-titanium
- Presence of an aneurysm in the SFA
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT01499342
Start Date
November 1 2009
End Date
February 1 2014
Last Update
August 22 2022
Active Locations (2)
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1
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600
2
University Hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000