ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

NCT ID: NCT00842296

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-05-31

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.

Conditions

Venous Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seg. RF Ablation with CLF catheter

Single Arm with CLF Catheter

Group Type: EXPERIMENTAL

RF ablation (ClosureFAST)

Intervention Type: DEVICE

Segmental RF Ablation with the CLF catheter

Interventions

RF ablation (ClosureFAST)

Segmental RF Ablation with the CLF catheter

Intervention Type: DEVICE

Other Intervention Names

CLF; CLosureFAST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Hasenbank, PhD

Role: STUDY_DIRECTOR

Medtronic

References

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.

Reference Type: DERIVED

PMID: 26992304 (View on PubMed)

Other Identifiers

CLF-05-03

Identifier Type: -

Identifier Source: org_study_id