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ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Venous Reflux
Intervention: Device: RF ablation (ClosureFAST)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from April 24, 2006- September 5, 2006. Medical offices/clinics and university hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (limbs)

Reporting Groups
  Description
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter

Participant Flow:   Overall Study
    ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Participants Units (limbs)
STARTED   326   396 
COMPLETED   326   396 
NOT COMPLETED   0    



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
326 patients were enrolled and 396 limbs were treated and are analyzed. Only 395 limbs provided baseline CEAP data.

Reporting Groups
  Description
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.

Baseline Measures
   ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei 
Overall Participants Analyzed 
[Units: Participants]
 326 
Overall Units Analyzed (Limbs) 
[Units: Limbs]
 396 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 326 
Participants Analyzed 
[Units: Participants]
 396 
Age   50.8  (13.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 326 
Participants Analyzed 
[Units: Participants]
 396 
Sex: Female, Male   
Female      239  60.4% 
Male      87  22.0% 
Region of Enrollment 
[Units: Participants]
 
Participants Analyzed 
[Units: Participants]
 326 
Participants Analyzed 
[Units: Participants]
 396 
United States   101 
Europe   225 
CEAP [1] [2] 
[Units: Limbs]
 
Participants Analyzed 
[Units: Participants]
 326 
Units Analyzed (Limbs) 
[Units: Limbs]
 395 
C0   1 
C1   5 
C2   213 
C3   110 
C4   60 
C5   4 
C6   2 
[1]

CEAP (Clinical/Etiology/Anatomy/Pathophysiology) Clinical Score:

C0: No visible/palpable sign C1: Reticular spider veins C2: Simple varicose veins C3: Ankle edema C4: Skin pigmentation C5: Healed venous ulcer C6: Open venous ulcer

395 out of 396 limbs reported a Baseline CEAP score.

[2] only 395 out of 396 limbs reported a Baseline CEAP score


  Outcome Measures

1.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 6 Months ]

2.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 12 months ]

3.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 2 years ]

4.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 3 years ]

5.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 4 years ]

6.  Primary:   Percentage of Limbs Without Vein Occlusion   [ Time Frame: 5 years ]

7.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 6 months ]

8.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 12 months ]

9.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 2 years ]

10.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 3 years ]

11.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 4 years ]

12.  Primary:   Percentage of Limbs Without Reflux in the Treated Vein Segment   [ Time Frame: 5 years ]

13.  Secondary:   CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification   [ Time Frame: Baseline ]

14.  Secondary:   CEAP Classification   [ Time Frame: 1 Week ]

15.  Secondary:   CEAP Classification   [ Time Frame: 3 months ]

16.  Secondary:   CEAP Classification   [ Time Frame: 12 months ]

17.  Secondary:   CEAP Classification   [ Time Frame: 5 years ]

18.  Secondary:   Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up   [ Time Frame: Baseline thru 5 years ]

19.  Secondary:   Visual Analog Pain Scale (VAS)   [ Time Frame: 5 years ]

20.  Secondary:   Presence of Complications From Greater Saphenous Vein (GSV) Intervention   [ Time Frame: 1 Week ]

21.  Secondary:   Presence of Complications From GSV Intervention   [ Time Frame: 3 Months ]

22.  Secondary:   Presence of Complications From GSV Intervention   [ Time Frame: 12 months ]

23.  Secondary:   Presence of Complications From GSV Intervention   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stephanie Brucato, Principal Clinical Research Specialist
Organization: Medtronic
phone: 508-261-8000
e-mail: stephanie.m.brucato@medtronic.com


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: March 12, 2018