ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

Medtronic

Status: Completed

Conditions: Venous Reflux

Treatments: Device: RF ablation (ClosureFAST)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00842296

CLF-05-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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326 participants in 1 patient group

Seg. RF Ablation with CLF catheter

Experimental group

Description:

Single Arm with CLF Catheter

Treatment:

Device: RF ablation (ClosureFAST)