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

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236245
• Other study ID #: VENC17A
• Status: Completed
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: August 2, 2021

Study information

• Verified date: March 2022
• Source: Venclose, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Venenzentrum am Bruehl	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Venclose, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vein Occlusion Rate	Percentage of limbs with occlusion of the treated vein	3 days
Primary	Vein Occlusion Rate	Percentage of limbs with occlusion of the treated vein	3 months
Primary	Vein Occlusion Rate	Percentage of limbs with occlusion of the treated vein	6 months
Primary	Vein Occlusion Rate	Percentage of limbs with occlusion of the treated vein	12 months
Primary	Reflux-free Rate	Percentage of limbs without reflux in the treated vein	3 days
Primary	Reflux-free Rate	Percentage of limbs without reflux in the treated vein	3 months
Primary	Reflux-free Rate	Percentage of limbs without reflux in the treated vein	6 months
Primary	Reflux-free Rate	Percentage of limbs without reflux in the treated vein	12 months
Secondary	Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	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)	Baseline
Secondary	Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	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)	3 days
Secondary	Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	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	3 months
Secondary	Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	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)	6 months
Secondary	Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification	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)	12 months
Secondary	Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	Baseline
Secondary	Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	3 days
Secondary	Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	3 months
Secondary	Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	6 months
Secondary	Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	12 months
Secondary	Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention	up to 3 days
Secondary	Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention	3 months
Secondary	Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention	6 months
Secondary	Presence of Complications From GSV Intervention	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention	12 months