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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion
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.
Time frame: 6 Months
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures \< 3 cm in length, does not constitute a failure.
Time frame: 12 months
Percentage of Limbs Without Vein Occlusion
Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.
Time frame: 2 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures \< 3 cm in length, does not constitute a failure.
Time frame: 3 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures \< 3 cm in length, does not constitute a failure.
Time frame: 4 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures \< 3 cm in length, does not constitute a failure.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 6 months
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 12 months
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 2 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 3 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 4 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
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.
Time frame: 5 years
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification
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.
Time frame: Baseline
CEAP Classification
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.
Time frame: 1 Week
CEAP Classification
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.
Time frame: 3 months
CEAP Classification
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.
Time frame: 12 months
CEAP Classification
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.
Time frame: 5 years
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up
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.
Time frame: Baseline thru 5 years
Visual Analog Pain Scale (VAS)
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
Time frame: 5 years
Presence of Complications From Greater Saphenous Vein (GSV) Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time frame: 1 Week
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time frame: 3 Months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time frame: 12 months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time frame: 5 years