Venous ObstructionNCT07095660
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
A study testing Recana procedure in people with Venous Obstruction, run by Intervene, Inc. at 1 site in Ireland.
Trial 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 postthrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Obstruction
- What is being tested?
- Recana procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 2 Jul 2025to 30 Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Provision of signed and dated informed consent form;
- Participant is 18 years of age and older;
- Neurologically stable;
- Ambulatory;
- Symptomatic chronic venous disease (CVD) with edema (CEAP classification of C3 or greater) or pain;
- Flow-limiting venous outflow obstruction (>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and
- Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
Who cannot join
- Comorbidity risks which may limit longevity (<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
- Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
- History of stroke within the last 6 months;
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
- Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks prior to consent;
- Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months prior to consent;
Show all 14Show fewer
- Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
- Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;
- Pregnant and/or breastfeeding;
- Patients with cognitive impairments who are unable to be consented;
- Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
- COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk;
- Patients considered to belong to a vulnerable population; and
- Inability to secure venous access and cross lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway
Eileen Coen, RN, 353 0861455568, eileen.coen@nuigalway.ie
Gerard O'Sullivan, MD
About this study
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 postthrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
- primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
- primary efficacy endpoint: patency greater than or equal to 50 percent (%) lumen diameter achieved 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. Qualified 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.
Read the 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 postthrombotic 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 postthrombotic 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.
- Conditions
- Venous Obstruction
- Being tested
- Recana procedure
- Keywords
- chronic venous disease, chronic venous insufficiency, CEAP classification of C3 or greater, flow-limiting venous outflow obstruction, postthrombotic syndrome, venous inflow/outflow obstruction
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recana procedureDevice
recanalization and debulking of obstructions and occlusions within stented and non-stented segments in veins
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | prospective, non-randomized treatment with the Recana Thrombectomy Catheter System Receives: Device: Recana procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure
The primary safety objective is procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
Measured: 30-days post-procedure
Primary Efficacy Endpoint - Patency greater than or equal to 50% Lumen Diameter in the Treated Vessel measured at time of procedure
The primary efficacy assessment is patency greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Jul 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ObstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intervene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard O'Sullivan, MD, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095660
- Sponsor's protocol ID
- CLN013
- Status last verified
- May 2026
- First submitted
- 23 Jul 2025
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
- ClinicalTrials.gov ID
- NCT07095660
- Acronym / sponsor ID
- CLN013
- Conditions
- Venous Obstruction
- Keywords
- chronic venous disease, chronic venous insufficiency, CEAP classification of C3 or greater, flow-limiting venous outflow obstruction, postthrombotic syndrome, venous inflow/outflow obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Intervene, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Jul 2025 (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 clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic postthrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
- primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
- primary efficacy endpoint: patency greater than or equal to 50 percent (%) lumen diameter achieved 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. Qualified 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 postthrombotic 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 postthrombotic 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: Recana procedureprospective, non-randomized treatment with the Recana Thrombectomy Catheter System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form;
- Participant is 18 years of age and older;
- Neurologically stable;
- Ambulatory;
- Symptomatic chronic venous disease (CVD) with edema (CEAP classification of C3 or greater) or pain;
Key exclusion criteria (14 listed)
- Comorbidity risks which may limit longevity (<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
- Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
- History of stroke within the last 6 months;
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
- Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks prior to consent;
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 |
|---|---|---|
| Recana procedurerecanalization and debulking of obstructions and occlusions within stented and non-stented segments in veins | Device | Open-label |
Primary outcome
Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure
Time frame: 30-days post-procedure
The primary safety objective is procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
Primary Efficacy Endpoint - Patency greater than or equal to 50% Lumen Diameter in the Treated Vessel measured at time of procedure
Time frame: Perioperative/Periprocedural
The primary efficacy assessment is patency greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
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 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Venous Obstruction
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
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.
Gerard O'Sullivan, MD principal investigator
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recana procedure in people with Venous Obstruction, run by Intervene, Inc. at 1 site in Ireland.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 May 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 Ireland. 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 ((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?
Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure (time frame: 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 27 May 2026.