Status:
COMPLETED
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
Lead Sponsor:
be Medical
Conditions:
Atherosclerotic Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
Eligibility Criteria
Inclusion
- Patient must sign informed consent prior to the index-procedure
- Patient must be older than 18 years
- Patient must be compliant with follow-up dates at 1 month and 12 months
- Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
- Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
- Reference vessel diameter ≥4.5 and ≤6.5 mm (visual estimate)
- Patients with a TASC A, B or C lesion
- Diameter stenosis of target lesion \>50% or chronic occlusions
- Inflow arteries are free of hemodynamically significant obstruction (i.e. ≥50%)
- The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. ≥50%)
- At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography
Exclusion
- Patients with Rutherford 1 and 6
- Patiens with Serum creatinine \> 2.0 mg/dL or renal dialysis
- Patient takes esomeprazole or omeprazole
- Patient is pregnant
- Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
- Target lesion cannot be crossed with a guidewire
- Target lesion is located in the popliteal artery
- Patients with a nickel-titanium allergy
- Patients with an aneurysm in the superficial femoral artery and popliteal artery
- Patients with a TASC D lesion
- Patients with a life expectancy \<1 year
- Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted
- Patients with previous bypass surgery in the SFA
- Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)
- Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure
- Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure
Key Trial Info
Start Date :
October 8 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2017
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01816854
Start Date
October 8 2012
End Date
March 29 2017
Last Update
December 20 2018
Active Locations (1)
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1
Antwerp University Hospital
Antwerp, Belgium, 2650