Chronic Venous Insufficiency
Conditions
Brief summary
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
Detailed description
Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.
Interventions
DEVICEBlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Sponsors
Intervene, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, non-randomized, multicenter pre-market feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6; * Failed compression therapy of at least 6 months' duration; * Deep system venous reflux characterized by \>1 second reflux time; * Presence of at least one target site within the target vessel.
Exclusion criteria
* Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms; * Deep venous intervention in the target limb or outflow vessels within 6 months of consent; * Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels; * Acute deep venous thrombosis (DVT) within 3 months of consent; * History of stroke within the last 6 months; * Flow-limiting venous outflow obstruction central to the intended target sites; * Insufficient inflow through the treatment vein upon manual augmentation; * Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites; * Chronic renal insufficiency with creatinine level of ≥2mg/dL; * Hemoglobin level \<9.0 mg/dL; * Platelet count \<50,000 or \>1,000,000 per mm3; * Total white blood cell count \<3,000/mm3; * Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested; * Non-ambulatory patients;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment | Baseline, 7-day, 30-day | Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up |
| Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) | 30-day post-procedure | Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment | 90-day, 210-day | Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging |
| Change in Reflux Time (RT) in the Primary Treated Vein Segment | 90-day, 210-day | Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline |
Countries
Australia, Canada, New Zealand
Contacts
STUDY_DIRECTORJeff Elkins
Intervene, Inc.
Participant flow
Pre-assignment details
Not applicable - Pre-assignment was not part of the protocol
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 7 |
| Anticoagulant Use at Baseline No | 6 Participants |
| Anticoagulant Use at Baseline Yes | 5 Participants |
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification C3 - edema | 0 Participants |
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification C4 - changes in skin and subcutaneous tissue secondary to chronic venous disease | 3 Participants |
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification C5 - healed | 3 Participants |
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification C6 - active venous ulcer | 5 Participants |
| Duration of Chronic Venous Insufficiency (CVI) | 12.2 years STANDARD_DEVIATION 14.2 |
| Prior Deep Vein Thrombosis (DVT) No | 8 Participants |
| Prior Deep Vein Thrombosis (DVT) Yes | 3 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
| Study Limb Left | 5 Participants |
| Study Limb Right | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 3 / 11 |
Outcome results
None listed