ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

• ClinicalTrials.gov Identifier: NCT00842296
• Recruitment Status: Completed
• First Posted: February 12, 2009
• Results First Posted: December 11, 2017
• Last Update Posted: March 12, 2018
• Sponsor: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

Tracking Information

• First Submitted Date: February 10, 2009
• First Posted Date: February 12, 2009
• Results First Submitted Date: June 26, 2017
• Results First Posted Date: December 11, 2017
• Last Update Posted Date: March 12, 2018
• Study Start Date: April 2006
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2017)

• Percentage of Limbs Without Vein Occlusion [ Time Frame: 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 Vein Occlusion [ Time Frame: 12 months ]
  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.
• Percentage of Limbs Without Vein Occlusion [ Time Frame: 2 years ]
  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.
• Percentage of Limbs Without Vein Occlusion [ Time Frame: 3 years ]
  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.
• Percentage of Limbs Without Vein Occlusion [ Time Frame: 4 years ]
  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.
• Percentage of Limbs Without Vein Occlusion [ Time Frame: 5 years ]
  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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 12 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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 2 years ]
  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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 3 years ]
  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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 4 years ]
  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.
• Percentage of Limbs Without Reflux in the Treated Vein Segment [ Time Frame: 5 years ]
  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.

• Original Primary Outcome Measures (submitted: February 11, 2009): Vein occlusion rate [ Time Frame: 3yr ]

Current Secondary Outcome Measures (submitted: February 12, 2018)

• CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification [ Time Frame: 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.
• CEAP Classification [ Time Frame: 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.
• CEAP Classification [ Time Frame: 3 months ]
  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.
• CEAP Classification [ Time Frame: 12 months ]
  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.
• CEAP Classification [ Time Frame: 5 years ]
  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.
• Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up [ Time Frame: 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) [ Time Frame: 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
• Presence of Complications From Greater Saphenous Vein (GSV) Intervention [ Time Frame: 1 Week ]
  Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
• Presence of Complications From GSV Intervention [ Time Frame: 3 Months ]
  Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
• Presence of Complications From GSV Intervention [ Time Frame: 12 months ]
  Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
• Presence of Complications From GSV Intervention [ Time Frame: 5 years ]
  Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

• Original Secondary Outcome Measures (submitted: February 11, 2009): Status of clinical signs and symptoms of lower limb venous disease [ Time Frame: 2 yr ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
• Official Title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element
• Brief 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Venous Reflux

Intervention

Device: RF ablation (ClosureFAST)

Segmental RF Ablation with the CLF catheter

Other Names:

• CLF
• CLosureFAST

Study Arms

Experimental: Seg. RF Ablation with CLF catheter

Single Arm with CLF Catheter

Intervention: Device: RF ablation (ClosureFAST)

• Publications *: Proebstle TM, Möhler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2017): 326
• Original Actual Enrollment (submitted: February 11, 2009): 396
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00842296
• Other Study ID Numbers: CLF-05-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Medtronic Endovascular
• Study Sponsor: Medtronic Endovascular
• Collaborators: Not Provided

Investigators

• Study Director: Melissa Hasenbank, PhD; Medtronic

• PRS Account: Medtronic Endovascular
• Verification Date: February 2018