Superficial vein therapies
VenaSeal Spectrum Program
Next-level evidence for venous care
Program overview
Purpose
The VenaSeal Spectrum Program is the largest post-market clinical study of the VenaSeal™ closure system compared to the current standards of care.
The VenaSeal Spectrum Program is:
- Comprised of three distinct studies.
- Designed to expand evidence across the spectrum of superficial venous disease.
- Designed with novel, patient-centered endpoints.
Design
- The outcomes of the VenaSeal treatments are compared to either endothermal ablation (ETA) or surgical stripping (SS) in two randomized controlled studies for the CEAP 2-5 population.
- The outcomes of the VenaSeal treatment are prospectively assessed in the treatment of active venous leg ulcer (VLU) patients in a separate single-arm study for the CEAP 6 population.
Primary endpoints
Venous treatment satisfaction questionnaire (TSQ)
Description
- Patient-centered primary endpoint in the VenaSeal Spectrum SS study and the VenaSeal Spectrum ETA study.
- Measures patient treatment satisfaction.
- Compares patient treatment satisfaction around the peri-procedural timepoint when treated with the VenaSeal closure system to other modalities such as endothermal ablation (ETA) or surgical stripping (SS).
- Assesses patient treatment satisfaction of venous leg ulcer (VLU) patients when treated with the VenaSeal closure system in the VenaSeal Spectrum VLU study.
Purpose
VenousTSQ is structured to capture patient satisfaction with vein treatment.
- New patient-reported outcome measure.
- Created to measure treatment satisfaction following superficial venous disease treatment.
- Designed to assess peri-procedural and longer-term patient treatment satisfaction measures identified by patients as important for treatment satisfaction/dissatisfaction.
Measurement
| VenousTSQ — Early |
|
|---|---|
| Peri-procedural patient treatment satisfaction measure |
Measured at 30 days post-procedure
|
| VenousTSQ — Status |
|
|---|---|
| Patient treatment satisfaction measure for longer-term follow-up |
Measured at 30 days, 6 months, and 12 months post-procedure |
Elimination of truncal reflux
Description
- Patient-centered primary endpoint in the VenaSeal Spectrum SS study and the VenaSeal Spectrum ETA study.
- Calculated by the percentage of target vein length successfully treated.
- Measured in each target vein at the time of index procedure.
Purpose
A more comprehensive approach at addressing patient symptoms.
- Captures the treated vein lengths as a percentage of the diseased vein (how much of the disease was actually treated).
Expands the definition of technical success to account for potential residual reflux outside of the treated segment.
Measurement
- Calculated as the percentage of diseased vein treated at index procedure.
- Actual treatment length ÷ length of diseased vein = % of treated vein.
Time to ulcer healing
Description
- Primary endpoint in the VenaSeal Spectrum VLU study.
- Patients enrolled in the venous leg ulcer (VLU) study have CEAP 6 disease or active leg ulcers and are treated with the VenaSeal closure system.
- Time to ulcer healing will be measured for each patient in follow-up visits.
Purpose
- While a correlation between venous interventions and leg ulcer healing is evident in the clinical literature, there is limited clinical evidence that exists regarding time to ulcer healing following the VenaSeal treatment.
Measurement
- In addition to the regular follow-up visits until 60 months, CEAP 6 will also have follow-up visits at 2, 3, 4, 5, 8, and 10 months until healing verification.
Global principal investigators
Kathleen Gibson,
M.D., FACS, FAVLS,
Vascular Surgeon
Lake Washington Vascular
Dr. Kathleen Gibson is the Global Principal Investigator for the VenaSeal Spectrum Program. She is a leading researcher in venous disease with numerous publications. Dr. Gibson also holds multiple leadership positions, including being President for AVLS.
Manjit Gohel,
MBChB, M.D., FRCS, FEBVS,
Consultant Vascular Surgeon and Honorary Senior Lecturer
Cambridge University Hospitals, Imperial College London
Mr. Gohel is the Global Principal Investigator for the VenaSeal Spectrum Program. An established investigator of chronic venous disease, Mr. Gohel's research has positively impacted clinical practice, notably the intervention of venous leg ulcers. He is a distinguished and highly influential member of several notable medical societies and congresses.
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