ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00842296

Enrollment

326

Registered

2009-02-12

Start date

2006-04-30

Completion date

2012-05-31

Last updated

2018-03-12

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

Conditions

Venous Reflux

Keywords

GSV, RadioFrequency

Brief summary

Detailed description

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

Interventions

DEVICERF ablation (ClosureFAST)

Segmental RF Ablation with the CLF catheter

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

* Age between 18 and 80 years of age at the time of enrollment * Symptomatic lower limb venous disease involving the GSV

Exclusion criteria

* Thrombosis in the vein segment to be treated * Known or suspected pregnancy or actively breast feeding at time of treatment

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Limbs Without Vein Occlusion	6 Months	Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures \< 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Reflux in the Treated Vein Segment	6 months	No reflux in the vein segment treated. Reflux was defined as reversal flow \>0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

Secondary

Measure	Time frame	Description
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up	Baseline thru 5 years	Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0). Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12.
Visual Analog Pain Scale (VAS)	5 years	Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification	Baseline	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The CEAP classification. Mayo Clinic Proc 1996;71:338-45.
Presence of Complications From GSV Intervention	3 Months	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Presence of Complications From Greater Saphenous Vein (GSV) Intervention	1 Week	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
CEAP Classification	1 Week	Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.

Participant flow

Recruitment details

Recruitment from April 24, 2006- September 5, 2006. Medical offices/clinics and university hospital.

Participants by arm

Arm	Count
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.	326
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.	396
Total	722

Baseline characteristics

Characteristic	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Age, Continuous	50.8 years STANDARD_DEVIATION 13.3
CEAP C0	1 limbs
CEAP C1	5 limbs
CEAP C2	213 limbs
CEAP C3	110 limbs
CEAP C4	60 limbs
CEAP C5	4 limbs
CEAP C6	2 limbs
Region of Enrollment Europe	225 participants
Region of Enrollment United States	101 participants
Sex: Female, Male Female	239 Participants
Sex: Female, Male Male	87 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 326
other Total, other adverse events	0 / 326
serious Total, serious adverse events	10 / 326