Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
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ClinicalTrials.gov Identifier: NCT01816854
Verified July 2015 by be Medical. Recruitment status was: Recruiting
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio > 2.4).
Secondary Outcome Measures
Immediate procedural outcome (procedural, technical and device success) [ Time Frame: peri-procedural ]
Procedural success: combination of technical success, device success and absence of procedural complications.
Technical success: successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography.
Device success: exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and in case of digital substraction angiography, in at least two different imaging projections.
Distribution of Rutherford stages [ Time Frame: 12 months ]
Primary sustained clinical improvement [ Time Frame: 12 months ]
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
Secondary sustained clinical improvement at 12 months [ Time Frame: 12 months ]
Defined as sustained upward shift of at least one category on the Rutherford classification including the need for repeated TLR in surviving patients.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).
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
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