N/A
N=43
Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins
Venous Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00565604 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Primary Effectiveness Objective — 53; 66 Treated IPVs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Short Catheter Delivery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vascular Solutions LLC
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Objective |
53; 66 | — |
| PRIMARY Primary Safety Objective |
14; 15 | — |
| SECONDARY Secondary Effectiveness Objective |
29; 27; 30; 34 | — |
| SECONDARY Secondary Safety Objective |
5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00565604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.