Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04349657
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2020-04-09
Brief Title:
A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
An RCT Evaluating the Safety and Efficacy of the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SUPERSURG-RCT
Brief Summary:
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery CFA of patients presenting with Rutherford classification 23 or 4 with a Supera Vascular Mimetic Implant of Abbott compared to classic surgical common femoral artery endarterectomy The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is when correctly implanted an ideal stent to treat eccentric calcified plaques in the CFA
An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery Assignment to the treatment groups will be at random
Patients will be invited for a follow-up visit at 1 6 12 24 and 36 months post-procedure
The primary efficacy endpoint is defined as follows freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months The primary safety endpoint is defined as follows a composite of overall death cardiac pulmonary renal complications sepsis target lesion revascularisation and wound related complications through 30 days post-index procedure
The secondary endpoints are defined as technical success primary patency in the deep femoral artery primary patency in the target lesion target lesion revascularisation target vessel revascularisation binary restenosis duration of initial hospital stay sustained clinical improvement change of walking impairment questionnaire score from baseline change in target limb Rutherford classification change in target limb ABITBI from baseline all cause death thrombosis at the target lesion through 6 12 24 and 36 months post-procedure
An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery Assignment to the treatment groups will be at random
Patients will be invited for a follow-up visit at 1 6 12 24 and 36 months post-procedure
The primary efficacy endpoint is defined as follows freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months The primary safety endpoint is defined as follows a composite of overall death cardiac pulmonary renal complications sepsis target lesion revascularisation and wound related complications through 30 days post-index procedure
The secondary endpoints are defined as technical success primary patency in the deep femoral artery primary patency in the target lesion target lesion revascularisation target vessel revascularisation binary restenosis duration of initial hospital stay sustained clinical improvement change of walking impairment questionnaire score from baseline change in target limb Rutherford classification change in target limb ABITBI from baseline all cause death thrombosis at the target lesion through 6 12 24 and 36 months post-procedure
Detailed Description:
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral artery Furthermore a non-inferiority hypothesis in terms of efficacy and a superiority in terms of safety will be tested with the endovascular treatment with Supera compared to surgical endarterectomy of the common femoral artery
The patients will be selected based on the investigators assessment evaluation of the underlying disease and the eligibility criteria The patients medical condition should be stable with no underlying medical condition which would prevent them from performing the required testing or from completing the study Patients should be geographically stable willing and able to cooperate in this clinical study and remain available for long term follow-up The patient is considered enrolled in the study after obtaining the patients informed consent if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion
Prior to the index procedure the following will be collected an informed consent for data collection demographics medical history medication record physical examination clinical category of acute limb ischemia Rutherford category the resting ankle-brachial index ABI or toe-brachial index TBI blood sample test complete blood count comprehensive metabolic panel and if applicable pregnancy test and a walking impairment questionnaire Randomization will also occur prior to the procedure
During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care For patients that are randomized within the Supera arm the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use Postdilatation of the stent is allowed but not mandatory
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure The patients will be invited for the following required follow-up visits at 1 6 12 24 and 36 months During these visit the following data will be collected medication record physical exam target limb ABITBI and Rutherford classification duplex ultrasound of target vessel walking impairment questionnaire and possible adverse events
The patients will be selected based on the investigators assessment evaluation of the underlying disease and the eligibility criteria The patients medical condition should be stable with no underlying medical condition which would prevent them from performing the required testing or from completing the study Patients should be geographically stable willing and able to cooperate in this clinical study and remain available for long term follow-up The patient is considered enrolled in the study after obtaining the patients informed consent if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion
Prior to the index procedure the following will be collected an informed consent for data collection demographics medical history medication record physical examination clinical category of acute limb ischemia Rutherford category the resting ankle-brachial index ABI or toe-brachial index TBI blood sample test complete blood count comprehensive metabolic panel and if applicable pregnancy test and a walking impairment questionnaire Randomization will also occur prior to the procedure
During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care For patients that are randomized within the Supera arm the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use Postdilatation of the stent is allowed but not mandatory
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure The patients will be invited for the following required follow-up visits at 1 6 12 24 and 36 months During these visit the following data will be collected medication record physical exam target limb ABITBI and Rutherford classification duplex ultrasound of target vessel walking impairment questionnaire and possible adverse events
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