VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Venous Reflux

• Registration Number: NCT03820947
• Lead Sponsor: Medtronic Endovascular

Brief Summary

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Detailed Description

The study is designed with two randomized studies and one single arm study.

Two randomized studies are for CEAP 2-5 subjects:

1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)

2. VenaSeal vs. ETA Study

The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

1. VLU Study

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Study Start: 2020-02-05
• Primary Completion: 2024-06-12
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

1. Patient is ≥18 years of age

2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by DUS

3. Eligibility for treatment:

   • VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
   • VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
   • VLU Study: patients should be eligible for treatment with the VenaSeal™ system

4. Treatable refluxing segment of target vein(s) 10 cm in length or longer

5. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing

6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times

7. Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria

1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity

2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care

3. Patient has abnormal pulse exam or ABI <0.8

4. Patient has acute superficial thrombophlebitis

5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure

6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)

7. IFU contraindications:

   • VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
   • VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
   • VLU Study: Patient has VenaSeal™ system IFU contraindication(s)

8. Patient is non-ambulatory

9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure

10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures

11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study

12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.

13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory

14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	Index procedure	Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	30 days	Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	30 days	Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
Time to ulcer healing (For VLU study)	Index procedure through 12 months	Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.

Secondary Outcome Measures

Name	Time	Method
Anatomic closure of the primary target superficial truncal vein	6 months	Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
Intra-procedural and post-procedural pain	Index procedure, and 7 days and 30 days	Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms	7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)	30 days	Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
Time to return to work	Through study completion, an average of 30 days
Anatomic closure of target vein	30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)	Measured via Duplex Ultrasound showing target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
Adverse events (AEs) occurring in the target limb	Index procedure through 12 months	Adverse events occurring in target limb, evaluated from index procedure through 12 months are hypersensitivity to VenaSeal™ adhesive, phlebitis, granuloma, endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), symptomatic deep vein thrombosis (DVT) events.
Additional adverse events	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)	Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).
Healthcare utilization measured by the number of each type of adjunctive treatment.	Index procedure through 12 months
Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease	Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Healthcare utilization measured by number of healthcare resources utilized for adverse events	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline	30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)	Items are scored on a 1-5 scale, 5 being a worse outcome. Each of the 5 dimensions are scored separately to obtain a 5-digit code which is converted into a standard value by country. Max \& min values vary by country.
Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline	30 days, and 6 and 12 months	The total score ranges from 0 to 100, with higher scores indicating better general health perception.
Provider experience evaluating overall satisfaction with the procedure	Index procedure	Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)	30 days	Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
Anatomic closure of primary target vein	30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)	Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized	Index procedure through 60 months
Technical success of each target vein	Index procedure	Measured via Duplex Ultrasound showing target vein (including primary target vein) closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
Reintervention of any target vein	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)	Assessed via number of the target veins requiring retreatment.
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline	30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)	The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.
For VLU Study: Percentage of target vein treated	Index procedure	Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time to reintervention of any target vein	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Time to return to normal activities	Through study completion, an average of 30 days
Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)	7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)	rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.
Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline	30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)	Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.
For VLU Study: Ulcer recurrence on the target limb	Following ulcer healing through 60 months
For VLU Study: Ulcer-free time	Through 60 months
For VLU study: Ulcer healing rate	Index procedure through 24 months or until ulcer healing has been confirmed

Trial Locations

Locations (32)

Yavapai Regional Medical Center; 🇺🇸 Prescott Valley, Arizona, United States

PIMA Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

Valley Vascular Surgical Associates; 🇺🇸 Fresno, California, United States

Vascular Care Connecticut; 🇺🇸 Darien, Connecticut, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Vascular Care Group; 🇺🇸 Wellesley, Massachusetts, United States

New York-Presbyterian Hospital/Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

OhioHealth Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

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