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

This study has been completed.
Sponsor:
Information provided by:
Vascular Solutions, Inc
ClinicalTrials.gov Identifier:
NCT00565604
First received: November 28, 2007
Last updated: February 21, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Venous Insufficiency
Device: Short Catheter Delivery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins The RELIEVE Study

Further study details as provided by Vascular Solutions, Inc:

Primary Outcome Measures:
  • Primary Effectiveness Objective [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

  • Primary Safety Objective [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.


Secondary Outcome Measures:
  • Secondary Effectiveness Objective [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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).

  • Secondary Safety Objective [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Safety: Incidence rate of device-related minor adverse events.


Enrollment: 43
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: Short Catheter Delivery
For treating incompetent perforator veins of the lower extremities
Other Name: Short Catheter 42-0664-01

Detailed Description:

This is a non randomized, single center clinical investigation, evaluating a total of fifty (50) limbs for the treatment of venous stasis ulcerations using the Vari-Lase laser.

Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. All subjects will have a mapping duplex ultrasound study in an Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) approved vascular laboratory. The ultrasound will verify the presence or absence of IPVs. The number, diameter, and location of the IPVs will be mapped. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent and be enrolled in the investigation. Upon satisfying all of the inclusion/exclusion criteria the subject will be accepted into the study.

After enrollment, the investigator will document the CEAP class, venous clinical severity score (VCSS), and venous disability score (VDS) in the subject's chart/medical record/source documentation for later transcription on the appropriate case report form. Digital photographs will be taken of the limb to be treated prior to treatment with the subject standing, following a standardized photography regimen.

All enrolled study participants will have a limb treated with the Vari-Lase laser manufactured by VSI. Subject preparation will be the same as for standard greater saphenous vein (GSV) or short saphenous vein, endovenous laser treatment. The initial technical success or failure of the procedure will be noted for each IPV and the pre-diameter of the IPV recorded. Multiple perforators may be treated in a single patient, as well as bilateral procedures allowed.

Follow-up duplex exams will be conducted within the first week of treatment and at 6 months. Follow-up duplex will verify patency vs. closure of IPV, and presence or absence of deep vein thrombosis (DVT) associated with that IPV. The goal is to prove successful closure of the treated IPVs veins as demonstrated by the duplex ultrasound at 6 weeks and show maintained closure of IPVs at 6 months.

Clinical examinations will occur at 2 weeks with an Associated Research Nurse Practitioner, at 6 weeks with the Medical Doctor, and at 6 months with either the Nurse Practitioner or Medical Doctor. At the 6 week visit, photos will be taken of the limb treated and there will be a reclassification of CEAP class, VDS, and VCSS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The subject has a history of significant arterial disease.
  2. 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.
  3. The subject has an Ankle Brachial Index (ABI) of < 0.5
  4. The subject has occlusive thrombosis in the vein segment to be treated.
  5. The subject has acute deep vein thrombosis.
  6. The subject has an active or systemic infection.
  7. The subject is or was enrolled in another investigational device or drug trial that may interfere with the results of this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565604

Locations
United States, Washington
Lake Washington Vascular Surgery
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Vascular Solutions, Inc
Investigators
Principal Investigator: Daniel Pepper, MD Lake Washington Vascular Surgery
  More Information

No publications provided

Responsible Party: Charmaine Sutton, Vascular Solutions, Inc.
ClinicalTrials.gov Identifier: NCT00565604     History of Changes
Other Study ID Numbers: 0107, Protocol CP1002
Study First Received: November 28, 2007
Results First Received: January 26, 2010
Last Updated: February 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vascular Solutions, Inc:
Perforator Veins
Incompetent Veins
Varicose Veins

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014