ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

NCT00842296 | Completed Results

• 1 other identifier: CLF-05-03
• Study Type: interventional
• Target: 326
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Reflux

Keywords

GSV; RadioFrequency

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification

  Baseline

• CEAP Classification

  1 Week

• CEAP Classification

  3 months

• CEAP Classification

  12 months

• CEAP Classification

  5 years

Study Arms (1)

Seg. RF Ablation with CLF catheter

EXPERIMENTAL

Single Arm with CLF Catheter

Device: RF ablation (ClosureFAST)

Interventions

RF ablation (ClosureFAST) DEVICE

Segmental RF Ablation with the CLF catheter

Also known as: CLF, CLosureFAST

Seg. RF Ablation with CLF catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years of age at the time of enrollment
• Symptomatic lower limb venous disease involving the GSV

You may not qualify if:

• Thrombosis in the vein segment to be treated
• Known or suspected pregnancy or actively breast feeding at time of treatment

Sponsors & Collaborators

• Medtronic Endovascular: lead

Related Publications (1)

• Proebstle TM, Mohler 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.

  PMID: 26992304 DERIVED

Results Point of Contact

• Title: Stephanie Brucato, Principal Clinical Research Specialist
• Organization: Medtronic

stephanie.m.brucato@medtronic.com

508-261-8000

Study Officials

• Melissa Hasenbank, PhD

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 12, 2009
• Study Start: April 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 12, 2018
• Results First Posted: December 11, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share