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Not yet recruitingNCT07529756CALIBERUpdated Oct 23, 2026

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

An observational study in Chronic Venous Disease, Chronic Venous Insufficiency, CVI and Venous Thrombosis, sponsored by Intervene, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Intervene, Inc. · Observational

Updated Oct 23, 2026First site in United StatesStart date moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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 obstructions. 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].

02

Conditions studied

  • Chronic Venous Disease
  • Chronic Venous Insufficiency, CVI
  • Venous Thrombosis
  • Thrombosis (Stent Thrombosis)
  • Thrombosis, Venous
  • Embolism and Thrombosis
  • Thrombectomy

Keywords

  • in-stent restenosis
  • venous outflow obstruction
  • thrombus
  • emboli
  • CALIBER Registry
  • recanalization
  • debulking
03

In context

Venous Thrombosis

785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.

This study's planned enrollment of 500 is above the median of 301 across 274 observational studies indexed under Venous Thrombosis.

Browse Venous Thrombosis studies →

Lead sponsor

Intervene, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 23, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects with lower extremity venous outflow obstruction

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

A. Native Vessel:

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

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: Subjects with obstructed stents in proximal lower extremity deep vein segments including common femoral, external iliac, and common iliac vein, and inferior vena cava alone or in combination, who, in the opinion of the investigator would benefit from treatment with the Recana
  4. INC-4: Recana Thrombectomy Catheter System must enter the vasculature
  5. INC-5: Willing and able to provide written informed consent

Exclusion criteria

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 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 to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  7. EXC-7: 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Primary Analysis Set (PAS) Population

    The Primary Analysis Set (PAS) population is a subset of the Full Analysis Set (FAS) population with unilateral or bilateral venous obstructions or occlusions without recent (≤3 months) venous intervention. The first 87 subjects in the FAS population who meet these criteria will complete the Primary Analysis Set population.

    Device: Recanalization and debulking

  • Full Analysis Set (FAS) Population

    The Full Analysis Set (FAS) population is defined as all consented subjects who are determined to be are appropriate candidates for treatment with the Recana Thrombectomy Catheter System and undergo the study procedure. The study will consist of up to 500 subjects in the FAS population.

    Device: Recanalization and debulking

  • Intention to Treat (ITT) Population

    The Intention-to-Treat (ITT) population is defined as all consented subjects who are determined to be candidates for treatment with the Recana Thrombectomy Catheter System, independent of the procedure being initiated or completed.

Interventions

  • DeviceRecanalization and debulking

    Recanalization and debulking with the Recana Thrombectomy Catheter System

06

What researchers measure

Primary outcomes

  1. Composite of Major Adverse Events (MAE)

    Composite of Major Adverse Events (MAE) where MAE is a combined clinical endpoint of death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism

    Time frame: From Index Procedure (Day 0) to 30-Days Post-Procedure

  2. Immediate Technical Success (Acute Procedural Success)

    • Defined as patency ≥50% luminal diameter measured by IVUS at the end of the procedure

    Time frame: Index Procedure (Day 0)

Secondary outcomes

  1. 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)

    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).

    Time frame: From Index Procedure (Day 0) to 30-Days Post-Procedure

  2. Incidence rate of device-related death

    Incidence rate (count) of any device-related death through 365-days post-procedure.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  3. Incidence rate of procedure-related death

    Incidence rate (count) of any procedure-related death through 365-days post-procedure.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  4. Patency rates of Target Venous Segment (TVS)

    TVS patency determined by duplex ultrasound or other imaging modality preferred by investigator through 365-days post-procedure.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  5. Incidence rate of device-related rethrombosis of the Target Venous Segment (TVS)

    Incidence rate (count) of device-related rethrombosis of the Target Venous Segment (TVS) through 365-days post-procedure.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  6. Incidence rate of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS)

    Incidence rate (count) of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS) through 365-days post-procedure.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  7. Comparison of baseline target limb edema to the 365-Days Post-Procedure score

    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.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  8. Comparison of baseline revised Venous Clinical Severity Score (rVCSS) to the rVCSS at 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,

    Time frame: From Index Procedure (Day 0) through study completion up assessed to 365-days post-procedure

  9. Comparison of baseline Villalta Score with the Villalta Score obtained 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.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  10. 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

    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.

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

Other outcomes

  1. Additional Safety Outcome Measures through 30-days post-procedure in the Primary Analysis Set (PAS) Population

    Incidence rate (count) of device-related serious adverse events (SAEs) that occur through 30-days post-procedure.

    Time frame: From Index Procedure (Day 0) through 30-Days Post-Procedure

  2. Additional Safety Outcome Measures through 365-days post-procedure in the Primary Analysis Set (PAS) Population

    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

    Time frame: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

  3. Post-procedural average effective stent diameter (percent) in the Primary Analysis Set (PAS) Population

    Post-procedure average effective stent diameter (percent) measured using intravascular ultrasound (IVUS).

    Time frame: Immediately after the intervention/procedure (Day 0)

  4. Post-procedural average inner lumen area (mm2) in the Primary Analysis Set (PAS) Population

    Post-procedural average inner lumen area (mm2) measured using intravascular ultrasound (IVUS).

    Time frame: Immediately after the intervention/procedure (Day 0)

  5. Incidence rate of post-thrombectomy balloon venoplasty in the Primary Analysis Set (PAS) Population

    Incidence rate (count) of balloon venoplasty during the procedure.

    Time frame: Index Procedure (Day 0)

  6. Incidence rate of post-thrombectomy stent placement in the Primary Analysis Set (PAS) Population

    Incidence rate (count) of stent placement due to residual thrombosis during the procedure.

    Time frame: Index Procedure (Day 0)

  7. Procedure Time in the Primary Analysis Set (PAS) Population

    Time (hours and/or minutes) required to complete the procedure.

    Time frame: From start time to end time of Index Procedure (Day 0)

  8. Hospitalization/Intensive Care Unit (ICU) Lengths of Stay in the Primary Analysis Set (PAS) Population

    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.

    Time frame: From Hospital Admission to Hospital Discharge for the index procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added — first site in United States
Show site
  • Oklahoma Heart Hospital · Oklahoma City, United States
Oct 23, 2026
Start date
Aug 2026→Oct 1, 2026
Oct 23, 2026
Eligibility
4 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedINC-2: ProximalSubject has lower extremity venous obstruction/occlusion involving the femoral, common femoral, and iliac veins, orand inferior vena cava (IVC), alone or in combination that, who, in the opinion of the investigator, would benefit from treatment with the Recana would benefit the patient
  • EditedINC-3: Recana Thrombectomy Catheter System must enter the vasculature
  • EditedINC-3: Location of thrombosedSubjects with obstructed stents in proximal lower extremity deep vein segments including common femoral, external iliac, and common iliac vein, orand inferior vena cava alone or in combination that, who, in the opinion of the investigator would benefit from treatment with the Recana would benefit the patient
  • EditedINC-4: Recana Thrombectomy Catheter System must enter the vasculature
Oct 23, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedImmediate Technical Success (Acute Procedural Success)Time frame: Index Procedure (Day 0)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    1 site added — first site in United States
    Show site
    • Oklahoma Heart Hospital · Oklahoma City, United States
    Start date Aug 2026→Oct 1, 2026
    Eligibility 4 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedINC-2: ProximalSubject has lower extremity venous obstruction/occlusion involving the femoral, common femoral, and iliac veins, orand inferior vena cava (IVC), alone or in combination that, who, in the opinion of the investigator, would benefit from treatment with the Recana would benefit the patient
    • EditedINC-3: Recana Thrombectomy Catheter System must enter the vasculature
    • EditedINC-3: Location of thrombosedSubjects with obstructed stents in proximal lower extremity deep vein segments including common femoral, external iliac, and common iliac vein, orand inferior vena cava alone or in combination that, who, in the opinion of the investigator would benefit from treatment with the Recana would benefit the patient
    • EditedINC-4: Recana Thrombectomy Catheter System must enter the vasculature
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedImmediate Technical Success (Acute Procedural Success)Time frame: Index Procedure (Day 0)
    + 5 other changes: index terms, identifiers, verification date, description and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07529756
Lead sponsor
Intervene, Inc.
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 23, 2026

Study contacts

Clinical Affairs Team
Contact
ClinSupport@intervene-med.com
650-995-7137
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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