Clinical trial NCT04236245: EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Official title: EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: GSV
superficial vein reflux
venous reflux
venous insufficiency
varicose veins
Lead sponsor: Venclose, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Detailed description: Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.

The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.

After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent).
* Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position.
* Subject is eligible for endovascular treatment, as determined by the treating investigator.
* Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator.
* Subject is willing and able to complete study requirements, including all follow-up visits and assessments.
* Subject voluntarily provides written informed consent to participate in this study.

Exclusion Criteria:

* There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure.
* In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated.
* Subject is concurrently participating in another interventional clinical trial.
* Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure.
* Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.

Primary outcomes:
measure: Vein Occlusion Rate
timeFrame: 3 days
measure: Vein Occlusion Rate
timeFrame: 3 months
measure: Vein Occlusion Rate
timeFrame: 6 months
measure: Vein Occlusion Rate
timeFrame: 12 months
measure: Reflux-free Rate
timeFrame: 3 days
measure: Reflux-free Rate
timeFrame: 3 months
measure: Reflux-free Rate
timeFrame: 6 months
measure: Reflux-free Rate
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
timeFrame: Baseline
measure: Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
timeFrame: 3 days
measure: Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
timeFrame: 3 months
measure: Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
timeFrame: 6 months
measure: Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
timeFrame: 12 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: Baseline
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 3 days
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 3 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 6 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 12 months
measure: Presence of Complications From GSV Intervention
timeFrame: up to 3 days
measure: Presence of Complications From GSV Intervention
timeFrame: 3 months
measure: Presence of Complications From GSV Intervention
timeFrame: 6 months
measure: Presence of Complications From GSV Intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Venenzentrum am Bruehl
Study officials:
affiliation: Venenzentrum am Bruehl
name: Thomas Mattausch, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.