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

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ClinicalTrials.gov Identifier: NCT03250247
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Ontario Clinical Oncology Group (OCOG) - McMaster University
VasCore - Massachusetts General Hospital
Mid America Heart Institute - St. Luke's Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Venous Stasis Venous Insufficiency Venous Leg Ulcer Venous Reflux Post Thrombotic Syndrome Device: Stents Not Applicable

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.

374 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. Clinical Centers, and followed for 24 months. The study will take approximately 6 years to complete.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.
Masking: Single (Outcomes Assessor)
Masking Description:

Clinical assessments for PTS will be obtained at baseline (pre-randomization) and at the 6, 12, 18 and 24-month follow-up visits. Examining clinicians will complete PTS training to ensure accuracy across all Clinical Centers. The examiners for PTS must be blinded to the subjects' treatment allocation. Subjects will be reminded not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon (the later the better) to allow the symptoms and signs of PTS to manifest. The assessment is performed as follows:

  1. The subject should be asked to rate the 5 symptoms on the Villalta PTS scale for each leg, record his/her ratings on the CRF.
  2. The subject's legs should be unclothed and he/she should be seated facing the blinded clinician (nurse or physician).The 5 signs of PTS and VCSS measures will be recorded by the blinded clinician. Leg ulcers (if present) will be assessed and measured.
Primary Purpose: Treatment
Official Title: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular Therapy - Intervention

All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.

Subjects randomized to EVT will receive the following:

  1. imaging-guided iliac vein stent placement, and
  2. endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic.
  3. optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care
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.


No Intervention: Non-Endovascular Therapy - Control
All subjects will receive optimal PTS care as noted above.



Primary Outcome Measures :
  1. PTS Severity [ Time Frame: over 6 months follow-up ]
    374 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with history of DVT; and b) either a Venous Clinical Severity Score (VCSS) > 8 or a Villalta PTS Scale score > 10 or an open venous ulcer); and
  2. Ipsilateral iliac vein obstruction documented within 3 months prior to screening by either:

    1. Occlusion 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:

  1. Age less than 18 years
  2. 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. Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter
  5. Chronic arterial limb ischemia (ankle-brachial index < 0.5)
  6. Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection in the ipsilateral leg
  7. Inability to tolerate endovascular procedure due to acute illness, or general health
  8. Severe allergy to iodinated contrast refractory to steroid premedication
  9. Known allergy to stent or catheter components
  10. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.5, or platelet count < 50,000/ml
  11. Severe renal impairment (estimated GFR < 30 ml/min)
  12. Disseminated intravascular coagulation or other major bleeding diathesis
  13. Pregnancy (positive pregnancy test)
  14. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
  15. Inability to provide informed consent or to comply with study assessments Note - patients who initially meet an exclusion criterion can be re-screened at a later date, and may be enrolled if all eligibility criteria are met at that time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250247


Contacts
Contact: Angela Oliver, RN, BSN, MS 314-747-8951 olivera@wustl.edu

  Show 27 Study Locations
Sponsors and Collaborators
Washington University School of Medicine
Ontario Clinical Oncology Group (OCOG) - McMaster University
VasCore - Massachusetts General Hospital
Mid America Heart Institute - St. Luke's Hospital
Investigators
Principal Investigator: Suresh Vedantham, M.D. Clinical Coordinating Center at Washington University School of Medicine

Publications of Results:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03250247     History of Changes
Other Study ID Numbers: 1UG3HL138325-01 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Washington University School of Medicine:
deep vein thrombosis
superficial venous reflux
blood clot
post thrombotic syndrome
iliac vein obstruction

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Leg Ulcer
Varicose Ulcer
Venous Insufficiency
Postphlebitic Syndrome
Postthrombotic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Varicose Veins
Phlebitis
Peripheral Vascular Diseases