Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05047302
Status:
WITHDRAWN
Last Update Posted:
2025-08-05
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)
Sponsor:
Intervene, Inc.
Organization:
Study Overview
Official Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project suspended by sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity.
Detailed Description:
STUDY DESIGN: The Study is a prospective, non-randomized study to evaluate participants treated with the BlueLeaf System for the restoration of deep venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility.
Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints.
STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6.
STUDY ENROLLMENT: Up to 50 subjects will be enrolled.
STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility.
Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints.
STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6.
STUDY ENROLLMENT: Up to 50 subjects will be enrolled.
Study Oversight
Has Oversight DMC:
True
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?: