VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Venous Reflux Clinical Trial

Official title:

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 & Advanced Stage Superficial Venous Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03820947
• Other study ID #: MDT18034
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: April 30, 2028

Study information

• Verified date: May 2024
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 506
• Est. completion date: April 30, 2028
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Venous Reflux

Intervention

Device:
• VenaSeal™ Closure System
The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
• Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Procedure:
• Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Locations

Country	Name	City	State
Australia	Sunshine Coast University Hospital	Birtinya
Australia	Wollongong Hospital	Wollongong
Canada	East Toronto Vascular Clinic	Toronto	Ontario
France	CHU Dijon Bourgogne	Dijon	DIjon Cedex
France	Clinique du Parc	Lyon
France	Clinique Pasteur	Toulouse
Germany	Praxis fur Innere Medizin und Gefäßkrankheiten	Halle
Italy	Ospedale Fatebenefratelli e Oftalmico	Milano
Italy	Azienda Ospedaliera di Padova Ospendale Sant' Antonio	Padova
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Netherlands	Rijnstate - Locatie Arnhem	Arnhem
Spain	Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)	Granada
Spain	Sanitas Hospital Universitario La Zarzuela	Madrid
United Kingdom	Bedfordshire Hospitals NHS Foundation Trust	Bedford
United Kingdom	Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital	Cambridge
United Kingdom	West London Vascular and Interventional Centre	Harrow
United Kingdom	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London
United States	Lake Washington Vascular	Bellevue	Washington
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	Vascular Care Connecticut	Darien	Connecticut
United States	Valley Vascular Surgical Associates	Fresno	California
United States	Orion Medical	Houston	Texas
United States	Yale School of Medicine	New Haven	Connecticut
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	Yavapai Regional Medical Center	Prescott Valley	Arizona
United States	PIMA Heart and Vascular	Tucson	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Vascular Care Group	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).	30 days
Primary	Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).	30 days
Primary	Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)	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.	Index procedure
Primary	Time to ulcer healing (For VLU study)	Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.	Index procedure through 12 months
Secondary	Anatomic closure of the primary target superficial truncal vein	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.	6 months
Secondary	Time to return to work		Through study completion, an average of 30 days
Secondary	Anatomic closure of primary target vein	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.	30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)
Secondary	Anatomic closure of target vein	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.	30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Technical success of each target vein	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.	Index procedure
Secondary	Reintervention of any target vein	Assessed via number of the target veins requiring retreatment.	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Time to reintervention of any target vein		Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Adverse events (AEs) occurring in the target limb	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.	Index procedure through 12 months
Secondary	Additional adverse events	Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).	Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Healthcare utilization measured by the number of each type of adjunctive treatment.		Index procedure through 12 months
Secondary	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)
Secondary	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)
Secondary	For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized		Index procedure through 60 months
Secondary	Time to return to normal activities		Through study completion, an average of 30 days
Secondary	Intra-procedural and post-procedural pain	Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.	Index procedure, and 7 days and 30 days
Secondary	Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)	rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.	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)
Secondary	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)
Secondary	Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline	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.	30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline	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.	30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline	The total score ranges from 0 to 100, with higher scores indicating better general health perception.	30 days, and 6 and 12 months
Secondary	Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline	Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.	30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary	Provider experience evaluating overall satisfaction with the procedure	Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).	Index procedure
Secondary	For VLU Study: Ulcer recurrence on the target limb		Following ulcer healing through 60 months
Secondary	For VLU study: Ulcer healing rate		Index procedure through 24 months or until ulcer healing has been confirmed
Secondary	For VLU Study: Ulcer-free time		Through 60 months
Secondary	For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)	Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).	30 days
Secondary	For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)	Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).	30 days
Secondary	For VLU Study: Percentage of target vein treated	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.	Index procedure