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ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 12, 2009
Results First Submitted Date  ICMJE June 26, 2017
Results First Posted Date  ICMJE December 11, 2017
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE April 2006
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: February 11, 2009)
Vein occlusion rate [ Time Frame: 3yr ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Reflux
Intervention  ICMJE Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
  • CLF
  • CLosureFAST
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2017)
326
Original Actual Enrollment  ICMJE
 (submitted: February 11, 2009)
396
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842296
Other Study ID Numbers  ICMJE CLF-05-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Melissa Hasenbank, PhD Medtronic
PRS Account Medtronic Endovascular
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP