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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerotic Heart Disease
• Intervention / Treatment: Device: Stenting

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PAD	Device: Stenting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		12 months
Immediate procedural outcome (procedural, technical and device success)	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.	peri-procedural
Distribution of Rutherford stages		12 months
Primary sustained clinical improvement	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.	12 months
Secondary sustained clinical improvement at 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.	12 months
Mortality	post-procedural	30-day mortality
Repeated target lesion revascularization (TLR) rate		12 months
Repeated target extremity revascularization (TER) rate		12 months
Amputation rate		12 months
Rate of patient clopidogrel resistance		1 month

Collaborators and Investigators

• Sponsor: be Medical
• Investigators: Principal Investigator: Jeroen Hendriks, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2012
• Primary Completion (ACTUAL): March 29, 2017
• Study Completion (ACTUAL): March 29, 2017

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (ESTIMATE): March 22, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Stenosis; Peripheral artery disease; SFA; Endovascular; PPA; Self-expandable nitinol stent; Primary pantency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: BM-HERO-07-001