Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT07219758
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Sponsor:
Intervene, Inc.
Organization:
Study Overview
Official Title:
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Status:
RECRUITING
Status Verified Date:
2025-10
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:
None
Brief Summary:
The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic post-thrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
2. primary efficacy endpoint: percent (%) lumen gain during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Participants are screened and qualified for the clinical investigation. Qualifed participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
2. primary efficacy endpoint: percent (%) lumen gain during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Participants are screened and qualified for the clinical investigation. Qualifed participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
Detailed Description:
STUDY DESIGN: The RECANA Study is a prospective, non-randomized, safety and performance (efficacy) study to evaluate participants treated with the Recana Thrombectomy Catheter System for the treatment of symptomatic post-thrombotic venous inflow/outflow obstruction.
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 starting on the day of the index procedure (considered Time 0) through 365 days post-procedure. All participants enrolled in the study are evaluated at screening/baseline, index procedure through hospital discharge, 30-days, 90-days,180 days and 365 days post-procedure. Duplex ultrasound, clinical assessments, quality of life, adverse events and concomitant medications are assessed at each follow-up visit.
STUDY POPULATION: Patients with symptomatic post-thrombotic venous inflow/outflow obstruction.
STUDY ENROLLMENT: Enrollment in the study is expected to take approximately 6-9 months. Follow up will continue through 12 months, therefore, the duration of the study is approximately 18-21 months.
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 starting on the day of the index procedure (considered Time 0) through 365 days post-procedure. All participants enrolled in the study are evaluated at screening/baseline, index procedure through hospital discharge, 30-days, 90-days,180 days and 365 days post-procedure. Duplex ultrasound, clinical assessments, quality of life, adverse events and concomitant medications are assessed at each follow-up visit.
STUDY POPULATION: Patients with symptomatic post-thrombotic venous inflow/outflow obstruction.
STUDY ENROLLMENT: Enrollment in the study is expected to take approximately 6-9 months. Follow up will continue through 12 months, therefore, the duration of the study is approximately 18-21 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: