Chronic Venous Insufficiency
Conditions
Brief summary
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
Interventions
DEVICERadiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Sponsors
Venclose, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is \>= 18 years. * IPVs to be treated have an outward flow duration of \>= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg. * IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle. * Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated. * Is able to ambulate. * Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study. * Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion criteria
* Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site. * Has thrombus in the vein segment to be treated. * Has untreated critical limb ischemia from peripheral arterial disease. * Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state. * Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively. * Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy). * Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure. * Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study. * Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure. * Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | 3-day post-procedure | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. |
| Effectiveness: Technical Success | Day of procedure | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. |
| Effectiveness: Successful Access and Entry Into the IPV | 3-day post ablation | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Ablation Success | 3-day post-procedure follow-up | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. |
| Reflux | 3-day post-procedure | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. | 27 |
| Single-arm: Endovascular Thermal Ablation in IPV Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. | 30 |
| Total | 57 |
Baseline characteristics
| Characteristic | Single-arm: Endovascular Thermal Ablation in IPV |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 14.2 |
| Body Mass Index (BMI) | 37.1 kg/m^2 STANDARD_DEVIATION 7.9 |
| CEAP Classification C0 | 0 IPVs |
| CEAP Classification C1 | 0 IPVs |
| CEAP Classification C2 | 0 IPVs |
| CEAP Classification C3 | 0 IPVs |
| CEAP Classification C4 | 13 IPVs |
| CEAP Classification C5 | 7 IPVs |
| CEAP Classification C6 | 10 IPVs |
| Height | 66.7 inches STANDARD_DEVIATION 18.5 |
| Number of Veins Female | 14 IPVs |
| Number of Veins Male | 16 IPVs |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
| Weight | 235.2 pounds STANDARD_DEVIATION 53.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Effectiveness: Successful Access and Entry Into the IPV
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time frame: 3-day post ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Effectiveness: Successful Access and Entry Into the IPV | 30 IPVs |
Primary
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time frame: 15-day post ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Effectiveness: Technical Success | 30 IPVs |
Primary
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time frame: 30-day post ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Effectiveness: Technical Success | 30 IPVs |
Primary
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Time frame: Day of procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Effectiveness: Technical Success | 30 IPVs |
Primary
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time frame: 3-day post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related AEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related SAEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | ADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | SADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | UADEs | 0 Events |
Primary
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time frame: 15-day post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | ADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related AEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related SAEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | SADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | UADEs | 0 Events |
Primary
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Time frame: 30-day post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related AEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related SAEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | ADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | SADEs | 0 Events |
| Single-arm: Endovascular Thermal Ablation in IPV | Safety: AEs, SAEs, ADEs, SADEs, UADEs | UADEs | 0 Events |
Secondary
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time frame: 3-day post-procedure follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Acute Ablation Success | 23 IPVs |
Secondary
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time frame: 15-day post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Acute Ablation Success | 22 IPVs |
Secondary
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Time frame: 30-day post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Acute Ablation Success | 24 IPVs |
Secondary
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time frame: 3-day post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Reflux | 26 IPVs |
Secondary
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time frame: 15-day post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Reflux | 25 IPVs |
Secondary
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Time frame: 30-day post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-arm: Endovascular Thermal Ablation in IPV | Reflux | 28 IPVs |