Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

BE Medical

Status: Completed

Conditions: Atherosclerotic Heart Disease

Treatments: Device: Stenting

Study type: Observational

Funder types: Industry

Identifiers

NCT01816854

BM-HERO-07-001

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%)
• 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 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
• 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

Trial design

117 participants in 1 patient group

Patients with PAD

Treatment:

Device: Stenting