Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

Deep Vein Thrombosis Clinical Trial

— C-TRACT  

Official title:

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250247
• Other study ID #: 201707130
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: April 27, 2026

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Mary Clare Derfler, RN MSN
• Phone: 314-973-0739
• Email: Derflerm[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 27, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Leg Ulcer
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Varicose Ulcer
• Venous Insufficiency
• Venous Leg Ulcer
• Venous Reflux
• Venous Stasis
• Venous Thrombosis

Intervention

Device:
• Stents
US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram of CFV through infrarenal IVC. Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein. The use of devices > 14 mm is highly recommended for the iliac vein and dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter. Balloon angioplasty of inflow veins. After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation. Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation.

Locations

Country	Name	City	State
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	NorthShore University Health System	Evanston	Illinois
United States	Northwestern University	Evanston	Illinois
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Gundersen Health System	La Crosse	Wisconsin
United States	AMITA Health Adventist	LaGrange	Illinois
United States	St. Elizabeth's Hospital	Lincoln	Nebraska
United States	UCLA	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	New York Presbyterian-Weill Cornell Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	Christiana Care Hospital	Newark	Delaware
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	St. Joseph's Vascular Institute	Orange	California
United States	Temple University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburg	Pittsburgh	Pennsylvania
United States	University of Vermont Health Network - CVPH	Plattsburgh	New York
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Intermountain Healthcare	Provo	Utah
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Louis University Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF	San Francisco	California
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Staten Island Hospital	Staten Island	New York
United States	Stony Brook Hospital	Stony Brook	New York
United States	Jobst Vascular Institute	Toledo	Ohio
United States	Central DuPage	Winfield	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Massachusetts General Hospital, Ontario Clinical Oncology Group (OCOG), St. Luke's Hospital, Kansas City, Missouri

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTS Severity	250 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated.	over 6 months follow-up