Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

Chalmers, Nicholas; Walker, Paul T.; Belli, Anna‐Maria; Thorpe, Anthony P.; Sidhu, Paul S.; Robinson, Graham J.; Ransbeeck, Mariella Van; Fearn, Steven A.

doi:10.1007/s00270-012-0492-z

Cited by 81 publications

(66 citation statements)

References 25 publications

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“…New generation stents are made from a nickel-titanium alloy (nitinol). Self-expanding nitinol stents have elastic and thermal memory properties and may resist torsion, flexion, extension, contraction, and compression of the femoropopliteal artery [53]. Stent diameter is slightly oversized (maximum 1 mm) compared with reference vessel size.…”

Section: Procedural Featuresmentioning

confidence: 99%

“…Stenting also may have a role in the treatment of anatomically complex lesions (eccentric calcified plaques, long-segment stenosis, and CTO) [6]. Although balloon angioplasty with provisional stent placement remains the standard of endovascular care, primary nitinol stent placement in the femoropopliteal arteries may reduce vessel restenosis and thereby decrease the need for repeat procedures in the mid-term according to several recent randomized, controlled trials [11,[51][52][53]. Nonetheless, primary stent placement in the femoropopliteal arteries remains controversial according to recent meta-analyses [54,55].…”

Section: Procedural Featuresmentioning

confidence: 99%

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Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Κατσάνος

Tepe

Tsetis

et al. 2014

Cardiovasc Intervent Radiol

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This is a Standards of Practice document endorsed by CIRSE. The authors performed a literature review and provide recommendations and quality improvement guidelines based on the most recent and highest level of evidence available to date on the field of Superficial Femoral and Popliteal Artery Angioplasty and Stenting. Standards for the use of basic and more advanced endovascular techniques in the femoropopliteal arteries are reported and relevant aspects of case selection, imaging, follow-up, and overall patient management are presented to guide endovascular practice in Europe.

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Section: Procedural Featuresmentioning

confidence: 99%

Section: Procedural Featuresmentioning

confidence: 99%

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Κατσάνος

Tepe

Tsetis

et al. 2014

Cardiovasc Intervent Radiol

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show abstract

“…4 Initial attempts to improve outcome using nondedicated stents proved futile. 5,6 Although contemporary dedicated nitinol stents have shown benefit over simple angioplasty and are now widely used to treat occlusive disease of the femoropopliteal artery, the 12-month patency remains far from ideal. 7,8 Furthermore, when drug-coated balloons are used primarily to treat disease in this area, there will still be a need for stents to treat suboptimal results.…”

mentioning

confidence: 99%

Helical Centerline Stent Improves Patency

Zeller

Gaines

Ansel

et al. 2016

Circ: Cardiovascular Interventions

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The self-expanding stent is laser cut from a nitinol tube and has a 3D helical centerline geometry set into the nitinol shape memory (Figure 1). The stent is an advanced design with repeating 2 crown units and specific connectors that allow both flexibility and helical geometry. The end 3 crowns have gradually reducing radial force to improve the transition in profile from artery to stent. It is Background-Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery. Methods and Results-In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided P<0.01) and efficacy (1-sided P<0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (P=0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months. Conclusions-Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years.However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.(Circ Cardiovasc Interv. 2016;9:e002930.

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“…11 This study randomized patients to either primary stenting (n=74) or PTA with bailout stenting (n=76), with an average targeted lesion length of 123±54.3 mm in the primary stenting group and 116.8±52.2 mm in the PTA group. Unlike previous studies, >90% of patients had total occlusive lesions.…”

Section: Interwoven Nitinol Stentmentioning

confidence: 99%

Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –

Yiu¹,

Conte²

2015

Circ J

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Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

Cited by 81 publications

References 25 publications

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Helical Centerline Stent Improves Patency

Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –

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Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

Cited by 81 publications

References 25 publications

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Helical Centerline Stent Improves Patency

Primary Stenting in Femoropopliteal Occlusive Disease – What Is the Appropriate Role? –

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Product

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Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –