The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry

Official title

The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry ("The CALIBER Registry")

Overview

The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are: * What is the observed rate of safety events through the 30-day follow-up? * What is the rate of technical success (acute procedural success) achieved at the index procedure? Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.

Detailed description

The CALIBER Registry is a prospective, multi-center, non-randomized, non-interventional (observational) registry of the Recana Thrombectomy Catheter System for the treatment of symptomatic venous obstruction and occlusions. Commensurate with the continuum of care and usual practice for the follow-up of the study population, subjects are assessed at post-procedure/discharge, 30-day (30D), 180-day (180D) and 365-day (365D) post-index procedure \[reporting on these timepoints are based on standard of care clinic visits that occur closest to timepoints at 30D, 180D and 365D post-procedure\].

Interventions

• Device Recanalization and debulking
  Recanalization and debulking with the Recana Thrombectomy Catheter System

Primary outcome measures

• Composite of Major Adverse Events (MAE) [Time frame: From Index Procedure (Day 0) to 30-Days Post-Procedure]
• Technical Success (Acute Procedural Success) [Time frame: Index Procedure (Day 0)]

Secondary outcome measures (10)

• Incidence rates of the following: (1) Individual components of the MAE composite endpoint; (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation) [Time frame: From Index Procedure (Day 0) to 30-Days Post-Procedure]
• Incidence rate of device-related death [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Incidence rate of procedure-related death [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Patency rates of Target Venous Segment (TVS) [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Incidence rate of device-related rethrombosis of the Target Venous Segment (TVS) [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Incidence rate of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS) [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Comparison of baseline target limb edema to the 365-Days Post-Procedure score [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Comparison of baseline revised Venous Clinical Severity Score (rVCSS) to the rVCSS at 365-Days Post-Procedure [Time frame: From Index Procedure (Day 0) through study completion up assessed to 365-days post-procedure]
• Comparison of baseline Villalta Score with the Villalta Score obtained 365-Days Post-Procedure [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]
• Comparison of baseline VEINES Quality of Life (QoL)/Symptom (Sym) Scores with the VEINES Quality of Life (QoL)/Symptom (Sym) Scores obtained 365-Days Post-Procedure [Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]

Eligibility criteria

INCLUSION CRITERA:

A. Native Vessel:

• INC-1: Subject is 18 years or older
• INC-2: Proximal lower extremity obstruction/occlusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient
• INC-3: Recana Thrombectomy Catheter System must enter vasculature
• INC-4: Willing and able to provide written informed consent

B. In-Stent Restenosis:

• INC-1: Subject is 18 years or older
• INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure
• INC-3: Location of thrombosed stents in proximal lower extremity deep vein segments including common femoral, external iliac, common iliac vein, or inferior vena cava alone or in combination that in the opinion of the investigator treatment with the Recana would benefit the patient
• INC-4: Recana Thrombectomy Catheter System must enter vasculature
• INC-5: Willing and able to provide written informed consent

EXCLUSION CRITERA

A. Native Vessel:

• EXC-1: IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
• EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
• EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
• EXC-4: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)
• EXC-5: Severe, life-threatening allergy to iodine or contrast dye
• EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• EXC-7: Life expectancy less than 1 year
• EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status
• EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period
• EXC-10: Inability to secure venous access and cross lesion
• EXC-11: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• EXC-12: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed

B. In-Stent Restenosis:

• EXC-1: Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
• EXC-2: Stent failure caused by undersizing or malapposition of the stent(s) \[For example, the segment of a stent in the iliac vein that is not wall apposed or cannot be apposed to the wall after balloon dilation is excluded. The segment of a stent that extends into the IVC that is not wall apposed would not be excluded.\]
• EXC-3: Stents compressed to <6mm that remain <6mm after balloon dilation
• EXC-4: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
• EXC-5: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
• EXC-6: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)
• EXC-7: Severe, life-threatening allergy to iodine or contrast dye
• EXC-8: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• EXC-9: Life expectancy less than 1 year
• EXC-10: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status
• EXC-11: Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• EXC-12: Inability to secure venous access and cross lesion
• EXC-13: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• EXC-14: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07529756 · CLN015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗