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ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842296
First Posted: February 12, 2009
Last Update Posted: December 11, 2017
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.
Information provided by (Responsible Party):
Medtronic Endovascular
  Purpose
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.

Condition Intervention Phase
Venous Reflux Device: RF ablation (ClosureFAST) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 assess 9 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.


Enrollment: 326
Study Start Date: April 2006
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seg. RF Ablation with CLF catheter
Single Arm with CLF Catheter
Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
  • CLF
  • CLosureFAST

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842296


Sponsors and Collaborators
Medtronic Endovascular
Investigators
Study Director: Melissa Hasenbank, PhD Medtronic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00842296     History of Changes
Other Study ID Numbers: CLF-05-03
First Submitted: February 10, 2009
First Posted: February 12, 2009
Results First Submitted: June 26, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Medtronic Endovascular:
GSV
RadioFrequency