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New treatment option for Venous Obstruction
Official title RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
ClinicalTrials.gov ID: NCT07219758
What this study is testing
- What it's testing
- 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 post-thrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are: 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Comorbidity risks which may limit longevity (\<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous...
- 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...
- treatment 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;
See the full eligibility criteria
- 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...
- Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
- 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...
- treatment 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.