Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06277362
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Peripheral Extreme Revascularization in No-option Patiens With Chronic Limb Threatening Ischemia
Sponsor:
EndoCore Lab srl
Organization:
EndoCore Lab srl
Study Overview
Official Title:
Arterial-Venous Reversal Flow in No-option Chronic Limb-threating Ischemia CLTI Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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:
PiPER
Brief Summary:
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice in an unselected population of patients with no-option CLTI
Detailed Description:
Critical lower Limb Threatening Ischemia is the most advanced stage of lower limb arterial disease and is associated with a high risk of mortality and major amputationLiterature data indicate that about 5-10 of patients with peripheral arterial disease have a risk of developing CLTI therefore the most advanced stage of arterial disease of the lower limbs within 5 years and have a mortality of 20 at 6 months after diagnosis of CLTIDespite the continuous improvement of the techniques and materials used in the revascularization of these patients the data of the Literature show that in about 10-15 of these patients revascularization is impossible or ineffective This condition is defined as no-option CLTITherefore for patients with no-option CLTI an alternative treatment for limb rescue may be considered the use of arterialization of the venous plexus of the foot that is to use to bring the arterial flow to the foot a healthy conduit such as the vein instead of the diseased artery and no longer usable
The present study is designed as a multicentre prospective single-arm observational study
All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data Once patients are enrolled their demographics medical history disease-relevant conditions treatment details and outcomes will be collected for up to 24 months from the procedure
The study will collect information about the medical care patients receive during their planned procedure No additional testing or procedures will be done
The revascularization procedure will be performed as per the current clinical practice
After discharge all patients will attend clinic visits at 30 days 7 days 6 months 14 days12 months 30 days 24 months 30 days
The present study is designed as a multicentre prospective single-arm observational study
All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data Once patients are enrolled their demographics medical history disease-relevant conditions treatment details and outcomes will be collected for up to 24 months from the procedure
The study will collect information about the medical care patients receive during their planned procedure No additional testing or procedures will be done
The revascularization procedure will be performed as per the current clinical practice
After discharge all patients will attend clinic visits at 30 days 7 days 6 months 14 days12 months 30 days 24 months 30 days
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