Clinical trial NCT05883943: Cook Venous Valve System for Treatment of Chronic Venous Insufficiency
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Venous Insufficiency of Leg
Lead sponsor: MED Institute Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from major adverse events in the first 30 days
timeFrame: 30 days after enrollment
Secondary outcomes:
measure: Freedom from MAE at three months, six months, and 12 months
timeFrame: Three months, six months, and 12 months after enrollment
Other outcomes:
Locations:
city: Antioquia
country: Colombia
facility: Angiosur S.A.S.
city: Barranquilla
country: Colombia
facility: Clínica de La Costa S.A.S.
city: Santander
country: Colombia
facility: Fundacion Oftalmologica De Santander
Study officials:
References: