Venclose digiRF System Post Market Study

Chronic Venous Insufficiency Clinical Trial

Official title:

Venclose digiRF System: A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05504070
• Other study ID #: BDPI-21-006
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: June 2027

Study information

• Verified date: January 2024
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 203
• Est. completion date: June 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is age 18 and older

2. Subject has CEAP clinical class C2 and higher.

3. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.

4. GSV/SSV or IPV to be treated that has an outward flow reflux duration of = 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.

5. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter =4.5 mm.

6. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of = 3.5 mm.

7. For IPV only: IPVs must be located under a healed or active ulcer.

8. Is able to ambulate.

9. Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.

10. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

Exclusion Criteria:

1. Has had previous treatment for venous insufficiency in the same target vein.

2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.

3. Has thrombus in the vein segment to be treated.

4. Has untreated critical limb ischemia from peripheral arterial disease.

5. Is undergoing active anticoagulant therapy for acute 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.

6. Subjects with known bleeding and/or clotting disorders.

7. Has ABI <0.8

8. Subject is pregnant or breastfeeding

9. For GSV/SSV only: has a BMI >35.

10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).

11. Unable to ambulate, or restrictive ambulation.

12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).

13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.

14. Has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency
• Venous Reflux

Intervention

Device:
• Venclose System (digiRF generator w EVSRF catheter)
The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
• Venclose MAVEN System (digiRF generator w MAVEN catheter)
The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.

Locations

Country	Name	City	State
United States	Englewood Hospital	Englewood	New Jersey
United States	Pacific Vascular Institute	Kailua	Hawaii
United States	Eastlake Cardiovascular	Roseville	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion	Cumulative Incidence of Occlusion	1-Month
Primary	DVT & PE Serious Adverse Events	Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events	1-Month
Secondary	revised Venous Clinical Severity Score (rVCSS)	Distribution of rVCSS score	Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
Secondary	ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)	Distribution of CIVIQ-20 score	Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits
Secondary	Clinical Etiological Anatomical Pathophysiological (CEAP)	Distribution of CEAP clinical class	Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
Secondary	Visual Analog Scale for Pain (VAS)	Distribution of VAS Pain score	Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
Secondary	Recanalization	Proportion of Recanalization of treated veins	1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
Secondary	Duration of Procedure	Mean Duration of Procedure	Day 1 Index Procedure visit
Secondary	Endovenous Heat Induced Thrombosis (2-4)	Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4	1-Month (+7 days) visit