NCT00565604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 17, 2011

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

November 28, 2007

Results QC Date

January 26, 2010

Last Update Submit

December 8, 2015

Conditions

Venous Insufficiency

Keywords

Perforator VeinsIncompetent VeinsVaricose Veins

Outcome Measures

Primary Outcomes (2)

  • Primary Effectiveness Objective

    The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein \[IPV\])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.

    6 Months

  • Primary Safety Objective

    Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.

    6 Months

Secondary Outcomes (2)

  • Secondary Effectiveness Objective

    6 Months

  • Secondary Safety Objective

    6 Months

Study Arms (1)

Short Catheter Delviery

EXPERIMENTAL

Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.

Device: Short Catheter Delivery

Interventions

Short Catheter DeliveryDEVICE

For treating incompetent perforator veins of the lower extremities

Also known as: Short Catheter 42-0664-01
Short Catheter Delviery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lake Washington Vascular Surgery

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Venous InsufficiencyVaricose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Daniel Pepper, MD
Organization
Lake Washington Vascular Surgery
(425) 453-1772

Study Officials

  • Daniel Pepper, MD

    Lake Washington Vascular Surgery

    PRINCIPAL INVESTIGATOR

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

November 28, 2007

First Posted

November 30, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 11, 2016

Results First Posted

March 17, 2011

Record last verified: 2015-12

Locations

US(1)