Clinical trial NCT01816854: Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
Official title: Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Heart Disease
Keywords: Peripheral artery disease
SFA
PPA
Self-expandable nitinol stent
Endovascular
Stenosis
Primary pantency
Lead sponsor: be Medical
Sponsor class: INDUSTRY
First posted: 2013-03-22
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).

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 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

Primary outcomes:
measure: Binary restenosis
timeFrame: 12 months
Secondary outcomes:
measure: Immediate procedural outcome (procedural, technical and device success)
timeFrame: peri-procedural
measure: Distribution of Rutherford stages
timeFrame: 12 months
measure: Primary sustained clinical improvement
timeFrame: 12 months
measure: Secondary sustained clinical improvement at 12 months
timeFrame: 12 months
measure: Mortality
timeFrame: 30-day mortality
measure: Mortality
timeFrame: 12 months
measure: Repeated target lesion revascularization (TLR) rate
timeFrame: 12 months
measure: Repeated target extremity revascularization (TER) rate
timeFrame: 12 months
measure: Amputation rate
timeFrame: 12 months
measure: Rate of patient clopidogrel resistance
timeFrame: 1 month
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Jeroen Hendriks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: