Trial Outcomes & Findings for Venclose RF Ablation System for the Treatment of IPVs (NCT NCT04386785)

Results Overview

Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

3-day post-procedure

Results posted on

2022-05-27

Participant Flow

Unit of analysis: Incompetent Perforator Veins

Participant milestones

Participant milestones
Measure	Single-arm: Endovascular Thermal Ablation in IPV Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Overall Study STARTED	27 30
Overall Study COMPLETED	27 30
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Venclose RF Ablation System for the Treatment of IPVs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Age, Continuous	67.8 years STANDARD_DEVIATION 14.2 • n=27 Participants
Sex: Female, Male Female	11 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
Weight	235.2 pounds STANDARD_DEVIATION 53.6 • n=27 Participants
Height	66.7 inches STANDARD_DEVIATION 18.5 • n=27 Participants
Body Mass Index (BMI)	37.1 kg/m^2 STANDARD_DEVIATION 7.9 • n=27 Participants
Number of Veins Female	14 IPVs n=30 IPVs
Number of Veins Male	16 IPVs n=30 IPVs
CEAP Classification C0	0 IPVs n=30 IPVs
CEAP Classification C1	0 IPVs n=30 IPVs
CEAP Classification C2	0 IPVs n=30 IPVs
CEAP Classification C3	0 IPVs n=30 IPVs
CEAP Classification C4	13 IPVs n=30 IPVs
CEAP Classification C5	7 IPVs n=30 IPVs
CEAP Classification C6	10 IPVs n=30 IPVs

PRIMARY outcome

Timeframe: 3-day post-procedure

Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=27 Participants Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related AEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related SAEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs ADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs SADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs UADEs	0 Events

PRIMARY outcome

Timeframe: 15-day post-procedure

Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=27 Participants Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related AEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related SAEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs ADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs SADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs UADEs	0 Events

PRIMARY outcome

Timeframe: 30-day post-procedure

Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=27 Participants Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related AEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs Procedure related SAEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs ADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs SADEs	0 Events
Safety: AEs, SAEs, ADEs, SADEs, UADEs UADEs	0 Events

PRIMARY outcome

Timeframe: Day of procedure

Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Effectiveness: Technical Success	30 IPVs

PRIMARY outcome

Timeframe: 3-day post ablation

Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Effectiveness: Successful Access and Entry Into the IPV	30 IPVs

PRIMARY outcome

Timeframe: 15-day post ablation

Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Effectiveness: Technical Success	30 IPVs

PRIMARY outcome

Timeframe: 30-day post ablation

Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Effectiveness: Technical Success	30 IPVs

SECONDARY outcome

Timeframe: 3-day post-procedure follow-up

The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Acute Ablation Success	23 IPVs

SECONDARY outcome

Timeframe: 15-day post-procedure

The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Acute Ablation Success	22 IPVs

SECONDARY outcome

Timeframe: 30-day post-procedure

The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Acute Ablation Success	24 IPVs

SECONDARY outcome

Timeframe: 3-day post-procedure

Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Reflux	26 IPVs

SECONDARY outcome

Timeframe: 15-day post-procedure

Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Reflux	25 IPVs

SECONDARY outcome

Timeframe: 30-day post-procedure

Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

Outcome measures

Outcome measures
Measure	Single-arm: Endovascular Thermal Ablation in IPV n=30 IPVs Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
Reflux	28 IPVs

Adverse Events

Single-arm: Endovascular Thermal Ablation in IPV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mai-Ly Wilcox

Venclose

Phone: 415-254-1930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place