Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins

Completed · Not applicable

Conditions studied: Venous Insufficiency

In brief

This trial is designed as a prospective, non randomized, single center clinical trial to determine the safety and efficacy of laser ablation of incompetent perforator veins. Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex ultrasound will verify the presence or absence of incompetent perforator veins (IPV). In addition, the number, diameter and location of the IPVs will be determined. Limbs with IPVs which measure greater than or equal to 3mm in diameter and are located superior to the foot and distal ankle will be considered for entry into the study.

Key facts

Study ID

NCT00565604

Run by

Vascular Solutions LLC

People needed

43

Starts

2007-10-01

Expected to finish

2009-06-01

Last updated by the study team

2016-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject is 18 years of age or older.
• The subject has the presence of incompetent perforator veins measuring > 3 mm in diameter resultant of reflux documented on duplex ultrasound.
• The subject has a CEAP classification of 3, 4, 5 or 6.
• The subject has incompetent perforator veins that are superior to the foot and distal ankle.
• The subject is willing and able to provide appropriate informed consent.
• The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

You may not qualify if…

• The subject has a history of significant arterial disease.
• The subject is known to be, or suspected to be, pregnant (verified in a manner consistent with institution's standard of care), or is lactating.
• The subject has an Ankle Brachial Index (ABI) of < 0.5
• The subject has occlusive thrombosis in the vein segment to be treated.
• The subject has acute deep vein thrombosis.
• The subject has an active or systemic infection.
• The subject is or was enrolled in another investigational device or drug trial that may interfere with the results of this trial.

Where it is running

• Lake Washington Vascular Surgery — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.