Chronic Venous Insufficiency
Conditions
Keywords
chronic venous insufficiency, varicose vein, greater saphenous vein
Brief summary
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.
Detailed description
Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.
Interventions
PROCEDUREAblation of the Incompetent Greater Saphenous Vein
For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
DEVICEClosureFAST radiofrequency catheter
DEVICEEVLT 980nm diode laser system
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic chronic venous insufficiency. * Patients in whom endovenous thermal ablation is clinically indicate. * Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices). * Have venous disease that meets CEAP clinical class 2 through 6. * Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse flow in the saphenous vein \>0.5 seconds after calf compression or while standing.
Exclusion criteria
* Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures). * Have a history of DVT. * Have a history of hypercoaguability disorder. * Are pregnant or breastfeeding. * Are nonambulatory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. | Annual follow up, up to 75 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Acute Complications | up to 6 weeks post intervention | Number of acute complications at one and 6 weeks post intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-procedure Pain | During post procedure recovery period in clinic, an expected average of 2 hours after surgery. | Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain. |
| Incidence of Objective Post-procedure Bruising | During post procedure recovery period in clinic, an expected average of 2 hours after surgery. | Measured with bruising scale, with a range of 1-10 with 10 being the most bruising. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Ablation Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
ClosureFAST radiofrequency catheter | 100 |
| Laser Ablation Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
EVLT 980nm diode laser system | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Radiofrequency Ablation | Laser Ablation | Total |
|---|---|---|---|
| Age, Continuous | 47 years | 48.5 years | 48 years |
| Race/Ethnicity, Customized Race/Ethnicity African American | 16 Participants | 18 Participants | 34 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 78 Participants | 70 Participants | 148 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 80 Participants | 77 Participants | 157 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.
Time frame: Annual follow up, up to 75 months
Population: The mean long-term followup in the EVLA group was 44 (12-64) months, and the mean long-term follow-up in the RFA group was 42 (12-75) months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Ablation | Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. | 79.3 percentage of total participants |
| Laser Ablation | Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. | 77.5 percentage of total participants |
Secondary
Incidence Rate of Acute Complications
Number of acute complications at one and 6 weeks post intervention
Time frame: up to 6 weeks post intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Ablation | Incidence Rate of Acute Complications | 0 number of complications |
| Laser Ablation | Incidence Rate of Acute Complications | 0 number of complications |
Other Pre-specified
Incidence of Objective Post-procedure Bruising
Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.
Time frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation | Incidence of Objective Post-procedure Bruising | 2 units on a scale |
| Laser Ablation | Incidence of Objective Post-procedure Bruising | 3 units on a scale |
Other Pre-specified
Incidence of Post-procedure Pain
Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.
Time frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation | Incidence of Post-procedure Pain | 1 units on a scale |
| Laser Ablation | Incidence of Post-procedure Pain | 3 units on a scale |