Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03368144
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2017-12-05
Brief Title:
Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of subacute Thrombotic Femoropopliteal Occlusions
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
Belgian Prospective Non-randomized Multi-center Controlled Physician-initiated Trial Evaluation of the Safety and Efficacy of the ClearLumen II Peripheral Thrombectomy System Recanalization of Acute and Subacute Thrombotic Femoropopliteal Occlusions
Status:
COMPLETED
Status Verified Date:
2021-09
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:
BELTHROM
Brief Summary:
The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal occlusions Acute Limb Ischemia ALI Rutherford I IIa IIb and III An expected total of 50 patients will be treated The lesion is located within the femoropopliteal artery native in-stent or bypass graft During the procedure the device is introduced activated and slowly advanced into the occlusion to clean out the wall-adherent thrombotic material If residual underlying stenosis of 30 persists additional endovascular treatment can be performed according to the physicians discretion Patients will be invited for a follow-up visit at 1 month post-procedure The primary efficacy endpoint is the technical success of the ClearLumen II Peripheral Thrombectomy System defined as removal of 90 acute clot as documented by angiography The primary safety endpoint is defined as the absence of device-related complications which is defined as embolization perforation or dissection caused by the ClearLumen II Peripheral Thrombectomy System Secondary endpoints include procedural success percent clot removed by the ClearLumen II Peripheral Thrombectomy System clinical success at 1 month follow-up visit 30-day target lesion revascularization 30-days serious adverse events and 30-days adverse events
Detailed Description:
The objective of this clinical investigation is to evaluate in a controlled setting the safety and efficacy of the recanalization of acute and subacute thrombotic up to 6 weeks femoropopliteal occlusions with the ClearLumen II Peripheral Thrombectomy System
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 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 acute limb ischemia Rutherford category and resting ankle-brachial index ABI
During the procedure the occlusion needs first to be recanalized by conventional guidewire technique since the ClearLumen II Peripheral Thrombectomy System is an over-the-wire system 0035 After assessment of the lesion by angiography via a common femoral artery approach contralateralipsilateral the occlusion is intraluminally crossed with the wire according to physicians discretion Afterwards the device is introduced and the catheter is activated Then the catheter is slowly advances into the occlusion Several passages of the occlusion may needed to clean out all wall-adherent thrombotic material If residual underlying stenosis of 30 persists additional endovascular treatment can be performed according to the physicians discretion
The regular follow-up is necessary to monitor the condition of the patient and the result of the procedure Patients will be invited for a follow-up visit 1 month after the index procedure The following data will be collected during this 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 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 acute limb ischemia Rutherford category and resting ankle-brachial index ABI
During the procedure the occlusion needs first to be recanalized by conventional guidewire technique since the ClearLumen II Peripheral Thrombectomy System is an over-the-wire system 0035 After assessment of the lesion by angiography via a common femoral artery approach contralateralipsilateral the occlusion is intraluminally crossed with the wire according to physicians discretion Afterwards the device is introduced and the catheter is activated Then the catheter is slowly advances into the occlusion Several passages of the occlusion may needed to clean out all wall-adherent thrombotic material If residual underlying stenosis of 30 persists additional endovascular treatment can be performed according to the physicians discretion
The regular follow-up is necessary to monitor the condition of the patient and the result of the procedure Patients will be invited for a follow-up visit 1 month after the index procedure The following data will be collected during this 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