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

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 \[reporting on these timepoints are based on standard of care clinic visits that occur closest to timepoints at 30D, 180D and 365D post-procedure\].

• Recanalization and debulking (Device): Recanalization and debulking with the Recana Thrombectomy Catheter System

Primary outcomes

• Composite of Major Adverse Events (MAE) [From Index Procedure (Day 0) to 30-Days Post-Procedure]: Composite of Major Adverse Events (MAE) where MAE is a combined clinical endpoint of death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism
• Technical Success (Acute Procedural Success) [Index Procedure (Day 0)]: * In-stent restenosis (ISR) venous segment: defined as patency ≥50% luminal diameter utilizing IVUS * Native venous segment: defined as patency ≥50% luminal diameter utilizing IVUS

Secondary outcomes

• 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) [From Index Procedure (Day 0) to 30-Days Post-Procedure]: Incidence rates (counts) through 30-days of 3 outcome measures: (1) Individual components of the MAE composite endpoint (death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism); (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation).
• Incidence rate of device-related death [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Incidence rate (count) of any device-related death through 365-days post-procedure.
• Incidence rate of procedure-related death [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Incidence rate (count) of any procedure-related death through 365-days post-procedure.
• Patency rates of Target Venous Segment (TVS) [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: TVS patency determined by duplex ultrasound or other imaging modality preferred by investigator through 365-days post-procedure.
• Incidence rate of device-related rethrombosis of the Target Venous Segment (TVS) [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Incidence rate (count) of device-related rethrombosis of the Target Venous Segment (TVS) through 365-days post-procedure.
• Incidence rate of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS) [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Incidence rate (count) of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS) through 365-days post-procedure.
• Comparison of baseline target limb edema to the 365-Days Post-Procedure score [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Target limb edema determined using the edema scale of the revised Venous Clinical Severity Score (rVCSS) at baseline (pre-procedure) will be compared to edema observed at 365-days post-procedure.
• Comparison of baseline revised Venous Clinical Severity Score (rVCSS) to the rVCSS at 365-Days Post-Procedure [From Index Procedure (Day 0) through study completion up assessed to 365-days post-procedure]: The revised Venous Clinical Severity Score (rVCSS) is comprised of 10 clinical categories. The scoring ranges from 0 (none) to 3 (severe) for each category, depending on the presence and severity of symptoms, signs, and the use of compression therapy. The scores are added to calculate the total rVCSS. A separate score is assigned to each leg. Total rVCSS ranges from 0 to 30, with higher numbers correlating to more severe symptoms, significant impairment to quality of life, and more advanced chronic venous insufficiency. The baseline rVCSS will be compared to the rVCSS obtained at 365-days post-procedure,
• Comparison of baseline Villalta Score with the Villalta Score obtained 365-Days Post-Procedure [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: The Villalta score is a clinical tool used to assess the severity of chronic venous disease (CVD) in the setting of Post Thrombotic Syndrome (PTS). The scoring ranges from 0 (none) to 3 (severe) based on the severity of signs and symptoms. A separate score is assigned to each leg. The total score for one leg is the sum of all scores for each symptom and clinical sign for that leg, and the total Villalta score ranges from 0 to 33 with higher scores correlating to worse outcomes (more severe clinical signs and symptoms). The presence of venous ulcers indicates severe PTS. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease. The baseline Villalta score will be compared to the Villalta score obtained at 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 [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: The VEINES-QoL/Sym is a 26-item, self-administered questionnaire measuring quality of life (QoL) and symptoms (Sym) in patients with chronic venous disorders or deep vein thrombosis (DVT). It evaluates symptom severity, frequency, and daily impact, providing two distinct scores - VEINES-QoL and VEINES-Sym - with higher scores indicating better outcomes. The VEINES-QoL component evaluates the impact of venous disease on daily life, social functioning, and physical limitations. The VEINES-Sym component assesses specific symptoms, including heavy legs, aching, swelling, night cramps, heat/burning, restless legs, throbbing, itching, and tingling. Scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The baseline VEINES-QoL/Sym scores will be compared to the VEINES-QoL/Sym scores obtained at 365-days post-procedure.

Other outcomes

• Additional Safety Outcome Measures through 30-days post-procedure in the Primary Analysis Set (PAS) Population [From Index Procedure (Day 0) through 30-Days Post-Procedure]: Incidence rate (count) of device-related serious adverse events (SAEs) that occur through 30-days post-procedure.
• Additional Safety Outcome Measures through 365-days post-procedure in the Primary Analysis Set (PAS) Population [From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure]: Overall rates (count) of the following that occur through 365-days post-procedure: 1. all reported adverse events (AEs) 2. hospital readmission 3. all-cause mortality 4. pulmonary embolism 5. major bleeding caused by vessel perforation
• Post-procedural average effective stent diameter (percent) in the Primary Analysis Set (PAS) Population [Immediately after the intervention/procedure (Day 0)]: Post-procedure average effective stent diameter (percent) measured using intravascular ultrasound (IVUS).
• Post-procedural average inner lumen area (mm2) in the Primary Analysis Set (PAS) Population [Immediately after the intervention/procedure (Day 0)]: Post-procedural average inner lumen area (mm2) measured using intravascular ultrasound (IVUS).
• Incidence rate of post-thrombectomy balloon venoplasty in the Primary Analysis Set (PAS) Population [Index Procedure (Day 0)]: Incidence rate (count) of balloon venoplasty during the procedure.
• Incidence rate of post-thrombectomy stent placement in the Primary Analysis Set (PAS) Population [Index Procedure (Day 0)]: Incidence rate (count) of stent placement due to residual thrombosis during the procedure.
• Procedure Time in the Primary Analysis Set (PAS) Population [From start time to end time of Index Procedure (Day 0)]: Time (hours and/or minutes) required to complete the procedure.
• Hospitalization/Intensive Care Unit (ICU) Lengths of Stay in the Primary Analysis Set (PAS) Population [From Hospital Admission to Hospital Discharge for the index procedure]: Total lengths of stay (reported in days and/or hours) spent in the hospital and/or ICU. This is calculated from time of hospital admission for the index procedure through hospital discharge.

Sex: All, ages: 18 Years to any

INCLUSION CRITERA:

A. Native Vessel:

1. INC-1: Subject is 18 years or older
2. 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
3. INC-3: Recana Thrombectomy Catheter System must enter vasculature
4. INC-4: Willing and able to provide written informed consent

B. In-Stent Restenosis:

1. INC-1: Subject is 18 years or older
2. INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure
3. 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
4. INC-4: Recana Thrombectomy Catheter System must enter vasculature
5. INC-5: Willing and able to provide written informed consent

EXCLUSION CRITERA

A. Native Vessel:

1. EXC-1: IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
2. EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
3. EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
4. 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)
5. EXC-5: Severe, life-threatening allergy to iodine or contrast dye
6. EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
7. EXC-7: Life expectancy less than 1 year
8. EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status
9. EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period
10. EXC-10: Inability to secure venous access and cross lesion
11. 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
12. 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:

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

• William A Marston, MD, Principal investigator, University of North Carolina
• Kush R Desai, MD, Principal investigator, Northwestern University
• Sameh Sayfo, MD, MBA, Principal investigator, Baylor Scott & White The Heart Hospital - Plano