Chronic Venous DiseaseCALIBERNCT07529756
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
An observational study of Chronic Venous Disease and Chronic Venous Insufficiency, CVI, run by Intervene, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease, Chronic Venous Insufficiency, CVI, Venous Thrombosis
- What is being tested?
- Recanalization and debulking
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Mar 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with lower extremity venous outflow obstruction
Who may be able to join
- Native Vessel:
- INC-1: Subject is 18 years or older
- 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
- INC-3: Recana Thrombectomy Catheter System must enter the vasculature
- INC-4: Willing and able to provide written informed consent
- In-Stent Restenosis:
Show all 11Show fewer
- INC-1: Subject is 18 years or older
- INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure
- 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
- INC-4: Recana Thrombectomy Catheter System must enter the vasculature
- INC-5: Willing and able to provide written informed consent
Who cannot join
- 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
Show all 28Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135
Parker Truong, DO, ptruong@okheart.com
Debby Schommer, RN, 405-608-1286, dschommer@okheart.com
About this study
Official title: The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry (CALIBER Registry)
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].
- Conditions
- Chronic Venous Disease, Chronic Venous Insufficiency, CVI, Venous Thrombosis, Thrombosis (Stent Thrombosis), Thrombosis, Venous, Embolism and Thrombosis
- Being tested
- Recanalization and debulking
- Keywords
- in-stent restenosis, venous outflow obstruction, thrombus, emboli, CALIBER Registry, recanalization, debulking
- Medical subject headings
- Blindness, Cortical, Venous Thrombosis, Thrombosis, Embolism and Thrombosis, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recanalization and debulkingDevice
Recanalization and debulking with the Recana Thrombectomy Catheter System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Index Procedure (Day 0) to 30-Days Post-Procedure
Immediate Technical Success (Acute Procedural Success)
- Defined as patency ≥50% luminal diameter measured by IVUS at the end of the procedure
Measured: Index Procedure (Day 0)
Secondary outcomes (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)
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).
Measured: From Index Procedure (Day 0) to 30-Days Post-Procedure
Incidence rate of device-related death
Incidence rate (count) of any device-related death through 365-days post-procedure.
Measured: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure
Incidence rate of procedure-related death
Incidence rate (count) of any procedure-related death through 365-days post-procedure.
Measured: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure
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.
Measured: 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)
Incidence rate (count) of device-related rethrombosis of the Target Venous Segment (TVS) through 365-days post-procedure.
Measured: 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)
Incidence rate (count) of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS) through 365-days post-procedure.
Measured: 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
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.
Measured: 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
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,
Measured: 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
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.
Measured: 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
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.
Measured: From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Intervene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A Marston, MD, Principal investigator, University of North CarolinaKush R Desai, MD, Principal investigator, Northwestern UniversitySameh Sayfo, MD, MBA, Principal investigator, Baylor Scott & White The Heart Hospital - Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529756
- Sponsor's protocol ID
- CLN015
- Acronym
- CALIBER
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry (CALIBER Registry)
- ClinicalTrials.gov ID
- NCT07529756
- Acronym / sponsor ID
- CALIBER / CLN015
- Conditions
- Chronic Venous Disease, Chronic Venous Insufficiency, CVI, Venous Thrombosis, Thrombosis (Stent Thrombosis), Thrombosis, Venous, Embolism and Thrombosis
- Keywords
- in-stent restenosis, venous outflow obstruction, thrombus, emboli, CALIBER Registry, recanalization, debulking
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Intervene, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Analysis Set (PAS) Population | – | Device: Recanalization and debulkingThe 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. |
| Full Analysis Set (FAS) Population | – | Device: Recanalization and debulkingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with lower extremity venous outflow obstruction
Key inclusion criteria (11 listed)
- Native Vessel:
- INC-1: Subject is 18 years or older
- 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
- INC-3: Recana Thrombectomy Catheter System must enter the vasculature
- INC-4: Willing and able to provide written informed consent
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recanalization and debulkingRecanalization and debulking with the Recana Thrombectomy Catheter System | Device | Full Analysis Set (FAS) Population, Primary Analysis Set (PAS) Population |
Primary outcome
Composite of Major Adverse Events (MAE)
Time frame: 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
Immediate Technical Success (Acute Procedural Success)
Time frame: Index Procedure (Day 0)
• Defined as patency ≥50% luminal diameter measured by IVUS at the end of the procedure
10 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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Disease and Chronic Venous Insufficiency, CVI, run by Intervene, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Affairs Team (650-995-7137, ClinSupport@intervene-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Major Adverse Events (MAE) (time frame: From Index Procedure (Day 0) to 30-Days Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.