EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04236245

Enrollment

Registered

2020-01-22

Start date

2020-05-11

Completion date

2021-08-02

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency

Keywords

GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins

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 After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.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.

Interventions

DEVICEVenclose RF System

Treatment of great saphenous vein (GSV) using Venclose RF System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Vein Occlusion Rate	3 days	Percentage of limbs with occlusion of the treated vein
Reflux-free Rate	3 days	Percentage of limbs without reflux in the treated vein

Secondary

Measure	Time frame	Description
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	Baseline	Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Venous Clinical Severity Score (VCSS)	Baseline	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Presence of Complications From GSV Intervention	up to 3 days	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Venclose RF System Treatment of great saphenous vein (GSV) using Venclose RF System Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System	25
Total	25

Baseline characteristics

Characteristic	Venclose RF System
Age, Continuous	54 years STANDARD_DEVIATION 10.8
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	25 Participants
Region of Enrollment Germany	25 participants
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 25
other Total, other adverse events	5 / 25
serious Total, serious adverse events	0 / 25

Outcome results

Primary