Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-27
Brief Title:
Fatigue Behavior of Peripheral STENt of the Superficial Femoral Artery
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
Atherosclerotic Pathology of the Superficial Femoral Arteries Study and Patient-specific Prediction of the Fatigue Behavior of Peripheral STENt in Nitinol Via Mathematical Modeling Prospective Enrollment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASTEN-PRO
Brief Summary:
Endovascular treatment of superficial femoral artery stenosisobstruction 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 372 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 fracturereocclusion could represent a help for the operator in choosing the best therapeutic strategy
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 372 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 fracturereocclusion could represent a help for the operator in choosing the best therapeutic strategy
Detailed Description:
The study involves the prospective collection of the following data
Preoperative vessel diameters plaque length plaque type percentage of stenosis position of the stenosis These data will be collected from the analysis of CT images magnetic resonance imaging color Doppler ultrasound or angiographies performed by patients in the diagnostic phase
Intraoperative number and model brand and size of stent implanted position of the stent The stents used are those foreseen by the usual clinical practice of each center In particular the behavior of the following stents will be analysed
or Absolute Pro Vascular Self-Expanding Stent System - ABBOTT VASCULAR or SMART Flex Vascular Self-Expanding Stent - CORDIS or LifeStent - BARD PV or Zilver - COOK MEDICAL
- Follow-up restenosis event stent fracture event In particular the restenosis event will be defined by the presence of a reduction in the caliber of the vessel morphologically greater than 30 or with PVR Peak Velocity Ratio peak systolic velocity in correspondence with the stenosispeak systolic velocity upstream in a non-stenotic tract recorded on color Doppler ultrasound 24 The stent fracture event will be defined by the presence of discontinuity images in the stent structure itself These data will be collected from the analysis of arterial color-Doppler ultrasound images of the lower limbs reference investigation foreseen by the study or other investigations CT magnetic resonance imaging angiographies performed by patients in the follow-up phase
The mathematical model
The computational analysis involves a reproduction via 3D model of the morphology of the pathological superficial femoral artery specific to the diagnostic data of the patients and the peripheral Nitinol stents used
The recanalizationdilation and stenting treatment is simulated using a finite element model taking into account the phases of the clinical procedure and the consequent cyclic stress conditions to which the device is subjected in vivo
The results of the computational model are analyzed in order to obtain the state of stress acting on the device and evaluate its risk of breakage
In particular the models created to reproduce the cases of the study will be developed using a commercial software in which the collected pre- and intraoperative parameters are entered and from which the prediction values of whether or not the superficial femoral stent will break will be extracted
The prediction given by the mathematical model will be compared with the data actually observed during the 3-year follow-up
The collected data will then be entered into a database and analyzed using the JMP 512 statistical software SAS Institute
Preoperative vessel diameters plaque length plaque type percentage of stenosis position of the stenosis These data will be collected from the analysis of CT images magnetic resonance imaging color Doppler ultrasound or angiographies performed by patients in the diagnostic phase
Intraoperative number and model brand and size of stent implanted position of the stent The stents used are those foreseen by the usual clinical practice of each center In particular the behavior of the following stents will be analysed
or Absolute Pro Vascular Self-Expanding Stent System - ABBOTT VASCULAR or SMART Flex Vascular Self-Expanding Stent - CORDIS or LifeStent - BARD PV or Zilver - COOK MEDICAL
- Follow-up restenosis event stent fracture event In particular the restenosis event will be defined by the presence of a reduction in the caliber of the vessel morphologically greater than 30 or with PVR Peak Velocity Ratio peak systolic velocity in correspondence with the stenosispeak systolic velocity upstream in a non-stenotic tract recorded on color Doppler ultrasound 24 The stent fracture event will be defined by the presence of discontinuity images in the stent structure itself These data will be collected from the analysis of arterial color-Doppler ultrasound images of the lower limbs reference investigation foreseen by the study or other investigations CT magnetic resonance imaging angiographies performed by patients in the follow-up phase
The mathematical model
The computational analysis involves a reproduction via 3D model of the morphology of the pathological superficial femoral artery specific to the diagnostic data of the patients and the peripheral Nitinol stents used
The recanalizationdilation and stenting treatment is simulated using a finite element model taking into account the phases of the clinical procedure and the consequent cyclic stress conditions to which the device is subjected in vivo
The results of the computational model are analyzed in order to obtain the state of stress acting on the device and evaluate its risk of breakage
In particular the models created to reproduce the cases of the study will be developed using a commercial software in which the collected pre- and intraoperative parameters are entered and from which the prediction values of whether or not the superficial femoral stent will break will be extracted
The prediction given by the mathematical model will be compared with the data actually observed during the 3-year follow-up
The collected data will then be entered into a database and analyzed using the JMP 512 statistical software SAS Institute
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None