ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

Venous Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842296
• Other study ID #: CLF-05-03
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: February 12, 2018
• Start date: April 2006
• Est. completion date: May 2012

Study information

• Verified date: February 2018
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Venous Reflux

Intervention

Device:
• RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Months
Primary	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.	12 months
Primary	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.	2 years
Primary	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.	3 years
Primary	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.	4 years
Primary	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.	5 years
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	2 years
Primary	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.	3 years
Primary	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.	4 years
Primary	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.	5 years
Secondary	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.	Baseline
Secondary	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.	1 Week
Secondary	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.	3 months
Secondary	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.	12 months
Secondary	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.	5 years
Secondary	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.	Baseline thru 5 years
Secondary	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	5 years
Secondary	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.	1 Week
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.	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.	5 years