Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03286361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-09
First Post:
2017-09-15
Brief Title:
Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
Belgo-France Physician-initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System for the Treatment of Iliac Lesions TASC A B C and D
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
BeGraftPMCF
Brief Summary:
The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions TASC A B C and D An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated The lesion is located within the native Iliac arteries Prior to stenting with the BeGraft Peripheral Plus Stent Graft System pre-dilatation can be performed according to the physicians discretion Also post-dilatation can be performed according to the physicians discretion Patients will be invited for a follow-up visit at 1 6 12 24 and 36- month post-procedure The primary efficacy endpoint of the study is the primary patency at 12 months The primary safety endpoint is the freedom of periprocedural Serious Adverse Events SAEs Secondary endpoint include primary patency rate at 1 6 24 and 36-month stent graft occlusion rate at pre-discharge1 6 24 and 36 month follow-up anke-brachial index ABI at 1 6 12 24 and 36-month follow-up amputation rate at 1 6 12 24 and 36-month follow-up performance success rate freedom from target lesion revascularization TLR technical success and clinical success at 1 6 12 24 and 36-month follow-up The extension in the Begraft Plus protocol is being made to evaluate the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft
Detailed Description:
The objective of this clinical investigation is to evaluate in a controlled setting the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC A B C and D iliac lesions
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 also be geographically stable willing and able to cooperate in this clinical study and remain available for long-term follow-up A 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 tests and clinical data will be collected informed consent for data collection demographics medical history medication record physical examination clinical category of chronic limb ischemia Rutherford category and resting ankle-brachial index ABI
During the procedure the vascular access can be achieved to the investigators standard clinical practice After successful lesion passage diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements vessel diameter percentage stenosis and lesion length are collected At the physicians discretion the patient receives at least 1 BeGraft Peripheral Plus Stent Graft System Pre- and post-dilatation are according to the physicians discretion No other adjunctive therapies atherectomy laser are allowed The complete iliac vasculature should be treated in one single session staged interventions are not allowed All outflow-limiting lesions must be treated according to the hospital treatment standard
The regular follow-ups are necessary to monitor the condition of the patient and the stentprocedure Patients will be invited for a follow-up visit at 1 6 12 24 and 36 months after the index procedure The following data will be collected during these follow-up visit medication record physical examination rutherford categorization ABI and color flow doppler ultrasound
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 also be geographically stable willing and able to cooperate in this clinical study and remain available for long-term follow-up A 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 tests and clinical data will be collected informed consent for data collection demographics medical history medication record physical examination clinical category of chronic limb ischemia Rutherford category and resting ankle-brachial index ABI
During the procedure the vascular access can be achieved to the investigators standard clinical practice After successful lesion passage diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements vessel diameter percentage stenosis and lesion length are collected At the physicians discretion the patient receives at least 1 BeGraft Peripheral Plus Stent Graft System Pre- and post-dilatation are according to the physicians discretion No other adjunctive therapies atherectomy laser are allowed The complete iliac vasculature should be treated in one single session staged interventions are not allowed All outflow-limiting lesions must be treated according to the hospital treatment standard
The regular follow-ups are necessary to monitor the condition of the patient and the stentprocedure Patients will be invited for a follow-up visit at 1 6 12 24 and 36 months after the index procedure The following data will be collected during these follow-up visit medication record physical examination rutherford categorization ABI and color flow doppler ultrasound
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