Clinical trial NCT03250247: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Official title: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Venous Stasis
Venous Insufficiency
Venous Leg Ulcer
Venous Reflux
Post Thrombotic Syndrome
Keywords: deep vein thrombosis
superficial venous reflux
blood clot
post thrombotic syndrome
iliac vein obstruction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ontario Clinical Oncology Group (OCOG)
name: Massachusetts General Hospital
name: Saint Luke's Mid America Heart Institute
First posted: 2017-08-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).

Detailed description: The rationale for performing the C-TRACT Trial is based upon:

1. the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon General's 2008 Call to Action on DVT (95);
2. the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;
3. the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS;
4. the ability of stent placement and endovenous ablation to eliminate obstruction and reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies;
5. the risks, costs, and uncertainties of this novel but invasive strategy;
6. the lack of consensus on whether EVT should be used for DIO-PTS;
7. the motivation of our established investigator team to answer this critical clinical question.

We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures.

250 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be enrolled over approximately 36 months in 20-40 U.S. Participants enrolled in C-TRACT protocol versions prior to 5.0 will be followed for 24 months. Subjects enrolled on protocol version 5.0 or after will be followed for 6 months. The study will take approximately 6 years to complete.

Eligibility criteria: Inclusion Criteria: Subjects must meet BOTH of these Criteria

1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease \> or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
2. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:

   1. Occlusion or \>50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
   2. Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.

Exclusion Criteria: Subjects meeting any of these criteria will be excluded.

1. Age less than 18 years
2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
5. Absence of PTS of at least moderate severity
6. Chronic arterial limb ischemia (ankle-brachial index \< 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)
7. Presence of open venous ulcer \> 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg
8. Inability to tolerate endovascular procedure due to acute illness, or general health
9. Severe allergy to iodinated contrast refractory to steroid premedication
10. Known allergy to stent or catheter components
11. Hemoglobin \< 8.0 g/dl, uncorrectable INR \> 3.05, or platelet count \< 75,000/ml
12. Severe renal impairment (on chronic dialysis or estimated GFR \< 30 ml/min)
13. Disseminated intravascular coagulation or other major bleeding diathesis
14. Pregnancy (positive pregnancy test)
15. Life-expectancy \< 6 months or chronically non-ambulatory for reasons other than PTS
16. Inability to provide informed consent or to comply with study assessments

Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

Primary outcomes:
measure: PTS Severity
timeFrame: over 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Orange
country: United States
facility: St. Joseph's Vascular Institute
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: LaGrange
country: United States
facility: AMITA Health Adventist
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Winfield
country: United States
facility: Central DuPage
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: St. Elizabeth's Hospital
state: Nebraska
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian-Weill Cornell Medicine
state: New York
city: Plattsburgh
country: United States
facility: University of Vermont Health Network - CVPH
state: New York
city: Staten Island
country: United States
facility: Staten Island Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburg
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Provo
country: United States
facility: Intermountain Healthcare
state: Utah
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Clinical Coordinating Center at Washington University School of Medicine
name: Suresh Vedantham, M.D.
role: PRINCIPAL_INVESTIGATOR
References: