Fatigue Behavior of Peripheral STENt of the Superficial Femoral Artery

NCT06198920 | Active Not Recruiting

• 1 other identifier: FASTEN-PRO V1 - 78/int/2017
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular treatment of superficial femoral artery stenosis/obstruction is still the subject of debate in the scientific literature. Previous clinical studies have in fact reported conflicting data regarding the benefits of implanting self-expanding Nitinol stents in the superficial femoral artery district compared to simple percutaneous transluminal angioplasty. Invariably, patient comorbidities and anatomic characteristics of the lesions appear to be important factors influencing procedural success and one-year patency rates. Additionally, there are concerns regarding the potential clinical impact of stent fractures, reported at rates ranging from 12% to 37.2% at one year. Despite the improved outcomes seen with newer Nitinol stent designs, the primary limitations of stenting in the superficial femoral artery are the use of multiple overlapping stents or long stents and the associated potential rate of stent fracture resulting reocclusion of the treated superficial femoral artery and clinical worsening of patients who in most cases are initially treated for disabling claudication. Being able to preoperatively determine in which patients there are risk factors prognostically associated with a higher rate of fracture/reocclusion could represent a help for the operator in choosing the best therapeutic strategy.

Conditions

Atherosclerosis; Stent Complication

Outcome Measures

Primary Outcomes (5)

• Rate of Stenting failure (restenosis/occlusion/fracture)

  determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.

  1 month

• Rate of Stenting failure (restenosis/occlusion/fracture)

  determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.

  6 months

• Rate of Stenting failure (restenosis/occlusion/fracture)

  determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.

  12 months

• Rate of Stenting failure (restenosis/occlusion/fracture)

  determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.

  24 months

• Rate of Stenting failure (restenosis/occlusion/fracture)

  determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.

  36 months

Interventions

Stenting of the superficial femoral artery PROCEDURE

Submitted to stenting of the superficial femoral artery for stenosis or occlusion causing intermittent claudication or critical limb ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by disabling intermittens claudication or critical limb ischemia due to stenosis/occlusion of the superficial femoral artery and treated with stenting of the superficial femoral artery

You may qualify if:

• adult patients (≥ 18 years) hospitalized in the Operating Units participating in the study and subjected to a recanalization/dilation and stenting procedure of the superficial femoral artery due to stenosis or obstruction of the same conditioning disabling claudication or critical ischemia of the lower limb (class 3-4-5-6 according to Rutherford).

You may not qualify if:

• minor patients (age \<18 years);
• patients who have not given their consent to participate in the study;
• Pregnant women.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (9)

• Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.

  PMID: 20484101 RESULT

• Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3.

  PMID: 24959692 RESULT

• Soga Y, Iida O, Hirano K, Yokoi H, Nanto S, Nobuyoshi M. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010 Sep;52(3):608-15. doi: 10.1016/j.jvs.2010.03.050. Epub 2010 Jun 22.

  PMID: 20573476 RESULT

• Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.

  PMID: 17592075 RESULT

• Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005 Jan 18;45(2):312-5. doi: 10.1016/j.jacc.2004.11.026.

  PMID: 15653033 RESULT

• Schlager O, Dick P, Sabeti S, Amighi J, Mlekusch W, Minar E, Schillinger M. Long-segment SFA stenting--the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005 Dec;12(6):676-84. doi: 10.1583/05-1672.1.

  PMID: 16363897 RESULT

• Ihnat DM, Duong ST, Taylor ZC, Leon LR, Mills JL Sr, Goshima KR, Echeverri JA, Arslan B. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg. 2008 May;47(5):967-74. doi: 10.1016/j.jvs.2007.12.050. Epub 2008 Apr 18.

  PMID: 18372147 RESULT

• Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Biamino G, Rubino P. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012 Oct 30;60(18):1739-42. doi: 10.1016/j.jacc.2012.07.033. Epub 2012 Oct 3.

  PMID: 23040582 RESULT

• Dordoni E, Meoli A, Wu W, Dubini G, Migliavacca F, Pennati G, Petrini L. Fatigue behaviour of Nitinol peripheral stents: the role of plaque shape studied with computational structural analyses. Med Eng Phys. 2014 Jul;36(7):842-9. doi: 10.1016/j.medengphy.2014.03.006. Epub 2014 Apr 12.

  PMID: 24721457 RESULT

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon, Researcher, PI

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: December 19, 2017
• Primary Completion: March 28, 2020
• Study Completion: March 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

IT (1)