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ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. (RECOVERY)

Primary Purpose

Venous Reflux

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Seg. RF Ablation & ClosureFAST catheter
Endovenous Laser
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Reflux focused on measuring Varicose veins, venous reflux, GSV disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects must provide written informed consent.
  • Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Exclusion Criteria:

  • Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
  • Subjects who are participating in another investigational study.

Sites / Locations

  • Oregon Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Seg. RF Ablation & ClosureFAST catheter

Endovenous Laser

Arm Description

Seg. RF Ablation & ClosureFAST catheter

Treatment invention of venous disease with an Endovenous Laser.

Outcomes

Primary Outcome Measures

Pain
Pain 0-10 scale (10 most severe)
Pain
Pain 0-10 scale (10 most severe)
Pain
Pain 0-10 scale (10 most severe)
Pain
Pain 0-10 scale (10 most severe)
Tenderness
Tenderness 0-10 scale (10 most severe)
Tenderness
Tenderness 0-10 scale (10 most severe)
Tenderness
Tenderness 0-10 scale (10 most severe)
Tenderness
Tenderness 0-10 scale (10 most severe)
Ecchymosis
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below treated (tx) segment
Ecchymosis
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Ecchymosis
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Ecchymosis
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Complications
Sequelae at any follow-up

Secondary Outcome Measures

VCSS
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
VCSS
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
VCSS
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
VCSS
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline

Full Information

First Posted
July 27, 2007
Last Updated
June 13, 2017
Sponsor
Medtronic Endovascular
Collaborators
VNUS Medical Technologies, A Covidien Company
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1. Study Identification

Unique Protocol Identification Number
NCT00509392
Brief Title
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Acronym
RECOVERY
Official Title
Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
Collaborators
VNUS Medical Technologies, A Covidien Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.
Detailed Description
Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Reflux
Keywords
Varicose veins, venous reflux, GSV disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seg. RF Ablation & ClosureFAST catheter
Arm Type
Active Comparator
Arm Description
Seg. RF Ablation & ClosureFAST catheter
Arm Title
Endovenous Laser
Arm Type
Active Comparator
Arm Description
Treatment invention of venous disease with an Endovenous Laser.
Intervention Type
Device
Intervention Name(s)
Seg. RF Ablation & ClosureFAST catheter
Other Intervention Name(s)
VNUS
Intervention Description
Seg. RF Ablation & ClosureFAST catheter
Intervention Type
Device
Intervention Name(s)
Endovenous Laser
Other Intervention Name(s)
Commercially approved laser catheter systems.
Intervention Description
laser catheter
Primary Outcome Measure Information:
Title
Pain
Description
Pain 0-10 scale (10 most severe)
Time Frame
48 Hour
Title
Pain
Description
Pain 0-10 scale (10 most severe)
Time Frame
1 Week
Title
Pain
Description
Pain 0-10 scale (10 most severe)
Time Frame
2 Weeks
Title
Pain
Description
Pain 0-10 scale (10 most severe)
Time Frame
1 Month
Title
Tenderness
Description
Tenderness 0-10 scale (10 most severe)
Time Frame
48 Hour
Title
Tenderness
Description
Tenderness 0-10 scale (10 most severe)
Time Frame
1 Week
Title
Tenderness
Description
Tenderness 0-10 scale (10 most severe)
Time Frame
2 Weeks
Title
Tenderness
Description
Tenderness 0-10 scale (10 most severe)
Time Frame
1 Month
Title
Ecchymosis
Description
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below treated (tx) segment
Time Frame
48 Hours post treatment (no baseline)
Title
Ecchymosis
Description
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Time Frame
1 Week post treatment (no baseline)
Title
Ecchymosis
Description
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Time Frame
2 Weeks post treatment (no baseline)
Title
Ecchymosis
Description
0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment
Time Frame
1 Month post treatment (no baseline)
Title
Complications
Description
Sequelae at any follow-up
Time Frame
1 month
Secondary Outcome Measure Information:
Title
VCSS
Description
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Time Frame
48 Hours
Title
VCSS
Description
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Time Frame
1 Week
Title
VCSS
Description
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Time Frame
2 Weeks
Title
VCSS
Description
Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Time Frame
1 Month
Title
Change in CIVIQ QOL
Description
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Time Frame
48 Hours
Title
Change in CIVIQ QOL
Description
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Time Frame
1 Week
Title
Change in CIVIQ QOL
Description
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Time Frame
2 Week
Title
Change in CIVIQ QOL
Description
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must provide written informed consent. Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser. Exclusion Criteria: Subjects who require additional treatments in either leg within 30 days before or after the study procedure. Subjects who are participating in another investigational study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lian Cunningham, MD
Organizational Affiliation
VNUS Medical Technologies, A Covidien Company
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health Sciences
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
19395275
Citation
Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.
Results Reference
result

Learn more about this trial

ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

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