Venous Insufficiency of LegNCT05883943
Cook Venous Valve System for Treatment of Chronic Venous Insufficiency
A study testing Cook® Venous Valve System in people with Venous Insufficiency of Leg, run by MED Institute Inc. at 3 sites in Colombia.
Trial summary
The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency of Leg
- What is being tested?
- Cook® Venous Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesColombia
- Study dates
- 24 Apr 2023to Sep 2028
- 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
Limited inclusion criteria:
- Documented symptomatic deep venous reflux in one limb
- Deep venous reflux in the region of interest
Limited exclusion criteria:
General:
- Age < 18 years
- BMI ≥ 40
- Cultural objections to porcine materials
- Unwillingness or inability to comply with the follow-up
- Unwillingness to provide study data for duration of study
- Simultaneous participation in another device or drug study
- Inability or refusal to give informed consent
Medical:
- Pregnant, or planning to become pregnant
- Diagnosis of terminal illness with life expectancy less than 12 months
- Complete symptom resolution with compliant compression therapy for three months
- Untreated superficial venous disease
- Medical interventions including any of the following: planned procedure of any leg, vascular intervention or major surgery within the last three months, implanted inferior vena cava filter
- Medical history of any of the following: anticoagulation treatment for pulmonary embolism (within the last six months or ongoing), insulin dependent diabetes, chronic obstructive pulmonary disease, renal dysfunction requiring dialysis, leg amputation, bleeding diathesis, untreated or unresolved systemic infection or local infection, active malignancy except non-melanoma skin cancer, other acute or chronic medical condition that may cause noncompliance with the protocol or confound the study results, documented history of significant untreated stenosis within the arterial system
- Positive coronavirus (COVID-19) test six days prior to implant procedure
Anatomical:
- Inability to clearly visualize target implantation site
- Tortuous target implantation site
- Inadequate inflow and/or outflow to the target region
Procedural:
- Inability to gain access to the access site vein
- Untreated focal or diffuse stenosis
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
Angiosur S.A.S.
Antioquia
Clínica de La Costa S.A.S.
Barranquilla
Fundacion Oftalmologica De Santander
Santander
About this study
Official title: First-in-Human Early Feasibility Clinical Evaluation of Safety, Efficacy and Utility of the Cook® Venous Valve System for Treatment of Chronic Venous Insufficiency
The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.
- Conditions
- Venous Insufficiency of Leg
- Being tested
- Cook® Venous Valve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook® Venous Valve SystemDevice
The Cook® Venous Valve is a permanent prosthetic, bicuspid, one-way flow valve designed to be percutaneously implanted into the peripheral deep venous system. The Cook® Venous Valve Delivery System is used to percutaneously deliver the Cook® Venous Valve into the deep venous system.
| Study group | Role | What they receive |
|---|---|---|
| Cook® Venous Valve System | Experimental | Not described Receives: Device: Cook® Venous Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events in the first 30 days
The primary safety endpoint is freedom from major adverse events (MAE) in the first 30 days, where MAE is defined as: death, clinically-driven reintervention, bleeding requiring transfusion, flow limiting dissection of the target vessel, or clinically significant deep vein thrombosis (DVT), pulmonary embolism, or device migration.
Measured: 30 days after enrollment
Secondary outcomes (1)
Freedom from MAE at three months, six months, and 12 months
The secondary safety endpoint is freedom from MAE at three months, six months, and 12 months.
Measured: Three months, six months, and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start24 Apr 2023
- Primary completion23 Sep 2023
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Insufficiency of LegStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883943
- Sponsor's protocol ID
- 21-4344
- Status last verified
- May 2026
- First submitted
- 15 May 2023
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Early Feasibility Clinical Evaluation of Safety, Efficacy and Utility of the Cook® Venous Valve System for Treatment of Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT05883943
- Acronym / sponsor ID
- 21-4344
- Conditions
- Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- MED Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Jun 2023 (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 purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cook® Venous Valve System | Experimental | Device: Cook® Venous Valve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cook® Venous Valve SystemThe Cook® Venous Valve is a permanent prosthetic, bicuspid, one-way flow valve designed to be percutaneously implanted into the peripheral deep venous system. The Cook® Venous Valve Delivery System is used to percutaneously deliver the Cook® Venous Valve into the deep venous system. | Device | Cook® Venous Valve System |
Primary outcome
Freedom from major adverse events in the first 30 days
Time frame: 30 days after enrollment
The primary safety endpoint is freedom from major adverse events (MAE) in the first 30 days, where MAE is defined as: death, clinically-driven reintervention, bleeding requiring transfusion, flow limiting dissection of the target vessel, or clinically significant deep vein thrombosis (DVT), pulmonary embolism, or device migration.
1 secondary outcome
Freedom from MAE at three months, six months, and 12 months
Time frame: Three months, six months, and 12 months after enrollment
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 19 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook® Venous Valve System in people with Venous Insufficiency of Leg, run by MED Institute Inc. at 3 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 19 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 3 sites in Colombia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse events in the first 30 days (time frame: 30 days after enrollment). 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 19 May 2026.