Trial Outcomes & Findings for Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins (NCT NCT00565604)

NCT ID: NCT00565604

Last Updated: 2016-01-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2016-01-11

Participant Flow

Subjects who had the presence of incompetent perforator veins were recruited from a medical clinic.

Two subjects were withdrawn from the study immediately after the index procedure due to failure to treat any incompetent perforator veins.

Participant milestones

Measure	Short Catheter Delivery 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.
Overall Study STARTED	43
Overall Study 7 Day	41
Overall Study 2 Week	41
Overall Study 6 Week	39
Overall Study 6 Month	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Short Catheter Delivery 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.
Overall Study Failure to treat	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Short Catheter Delivery n=43 Participants 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.
Age, Continuous	54.1 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: The number of patients still participating in the study at 6-months.

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.

Outcome measures

Measure	Short Catheter Delivery n=76 Treated IPVs 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.
Primary Effectiveness Objective IPV Closure-6 months	53 Treated IPVs
Primary Effectiveness Objective IPV Closure-6 weeks	66 Treated IPVs

PRIMARY outcome

Timeframe: 6 Months

Population: The number of patients that were enrolled in the study.

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

Outcome measures

Measure	Short Catheter Delivery n=43 Participants 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.
Primary Safety Objective Major Device-Related Adverse Events through 6 week	14 Participants
Primary Safety Objective Major Device-Related Adverse Events Total 6 months	15 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: The number of patients still participating in the study at 6-months.

Effectiveness: The reduction in patient symptoms and the satisfaction of the patient. Patient symptom assessment - CEAP Class, best=0 (no visible or palpable signs of venous disease) & worst=6 (Skin changes in conjunction with active ulceration), VDS, best=0 (asymptomatic) & worst=3 (unable to carry out usual activities even with compression and/or limb elevation) and VCSS, best=0 (absent) & worst=3 (severe). Patient satisfaction - modified Odom's criteria, best=excellent (I am very satisfied with the results of my laser treatment) & worst=poor (I am not satisfied with the results).

Outcome measures

Measure	Short Catheter Delivery n=39 Participants 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.
Secondary Effectiveness Objective CEAP Class Improved	29 Participants
Secondary Effectiveness Objective VCSS Improved	27 Participants
Secondary Effectiveness Objective VDS Improved	30 Participants
Secondary Effectiveness Objective Patient Satisfaction (Good or Excellent)	34 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: The number of subjects that were enrolled in the trial.

Safety: Incidence rate of device-related minor adverse events.

Outcome measures

Measure	Short Catheter Delivery n=43 Participants 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.
Secondary Safety Objective	5 Participants

Adverse Events

Short Catheter Delivery

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Short Catheter Delivery n=43 participants at risk 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.
Blood and lymphatic system disorders Deep Vein Thrombosis	14.0% 6/43 • Number of events 6 • 6 months Subjects were assessed for adverse events at 1-week, 2-week, 6-week and 6-month follow-up office visits
Nervous system disorders Paresthesia	25.6% 11/43 • Number of events 11 • 6 months Subjects were assessed for adverse events at 1-week, 2-week, 6-week and 6-month follow-up office visits

Additional Information

Daniel Pepper, MD

Lake Washington Vascular Surgery

Phone: (425) 453-1772

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60