NCT01816854
Completed
Not Applicable
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
be Medical1 site in 1 country117 target enrollmentOctober 8, 2012
ConditionsAtherosclerotic Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerotic Heart Disease
- Sponsor
- be Medical
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Binary restenosis
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Binary restenosis
Time Frame: 12 months
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio \> 2.4).
Secondary Outcomes
- Immediate procedural outcome (procedural, technical and device success)(peri-procedural)
- Distribution of Rutherford stages(12 months)
- Primary sustained clinical improvement(12 months)
- Secondary sustained clinical improvement at 12 months(12 months)
- Mortality(12 months)
- Repeated target lesion revascularization (TLR) rate(12 months)
- Rate of patient clopidogrel resistance(1 month)
- Repeated target extremity revascularization (TER) rate(12 months)
- Amputation rate(12 months)
Study Sites (1)
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