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

Completed

• Conditions: Atherosclerotic Heart Disease
• Interventions: Device: Stenting

• Registration Number: NCT01816854
• Lead Sponsor: be Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-08
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PAD	Stenting	-

Primary Outcome Measures

Name	Time	Method
Binary restenosis	12 months	Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio \> 2.4).

Secondary Outcome Measures

Name	Time	Method
Mortality	12 months
Immediate procedural outcome (procedural, technical and device success)	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	12 months
Primary sustained clinical improvement	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	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.
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

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium