Catheter-Directed Therapy for Post-Thrombotic Syndrome

(C-TRACT Trial)

Not currently recruiting at 35 trial locations

Overseen By Mary Clare Derfler, RN MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Age < 18, Acute DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if endovascular therapy (EVT), which uses imaging to guide stent placement, can reduce the severity of Post-Thrombotic Syndrome (PTS) and improve the quality of life for those affected. PTS often causes significant discomfort and limits daily activities due to vein issues, typically following a deep vein thrombosis (DVT), a clot in a vein. The trial compares standard care alone to standard care plus EVT. Ideal participants have experienced moderate-to-severe PTS for at least three months, with symptoms that significantly limit daily life or work. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future treatment options for PTS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this endovascular therapy is safe for treating post-thrombotic syndrome?

Research has shown that using stents in endovascular therapy offers a promising and safe treatment for post-thrombotic syndrome (PTS). Studies have found that patients generally respond well to this method, often achieving successful outcomes. One study demonstrated excellent results with angioplasty and stenting, procedures that widen veins using a small tube.

Safety data from various studies indicate that serious side effects are rare. Preventing blood clots in the stent after placement remains a priority. Medications like aspirin combined with rivaroxaban, a blood thinner, manage this risk effectively. This combination proves more effective than rivaroxaban alone. Overall, research suggests that endovascular therapy with stents safely and effectively manages PTS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the endovascular therapy for post-thrombotic syndrome (PTS) because it offers a targeted approach to managing the condition. Unlike standard treatments that mainly focus on symptom management with compression stockings and medications, this therapy directly addresses the blocked or narrowed veins by placing stents and performing endovenous ablation. This method not only aims to improve blood flow but also tackles the underlying causes of PTS, potentially providing more effective and lasting relief for patients. By incorporating imaging-guided techniques, it promises a more precise and personalized intervention, which is a significant advancement over conventional care.

What evidence suggests that this endovascular therapy is effective for reducing Post Thrombotic Syndrome?

This trial will compare two approaches for managing post-thrombotic syndrome (PTS). Participants in the Endovascular Therapy arm will receive image-guided, catheter-based treatments, including iliac vein stent placement and endovenous ablation of refluxing saphenous veins. Studies have shown that stent placement can effectively address blockages in the iliac vein, improving blood flow and reducing symptoms. Research also indicates that endovenous thermal ablation is safe and effective for individuals who have had deep vein thrombosis. Together, these treatments aim to reduce the severity of PTS and enhance patients' overall quality of life. Participants in the Non-Endovascular Therapy arm will receive optimal PTS care without these interventions. ^{6 7 8 9 10}

Who Is on the Research Team?

Suresh Vedantham, M.D.

Principal Investigator

Clinical Coordinating Center at Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with severe post-thrombotic syndrome (PTS) due to a history of deep vein thrombosis, who have leg symptoms or ulcers affecting daily life. They must have documented iliac vein blockage and be able to walk. Excluded are those with less than 6 months to live, previous stents in certain veins, severe allergies to materials used in the procedure, pregnant women, inability to consent or follow-up, certain blood conditions, recent DVTs, severe kidney issues or limb ischemia.

Inclusion Criteria

I have severe post-thrombotic syndrome in my leg that limits my daily activities.

I have a blockage in the vein of my leg documented in the last year.

Subjects must meet BOTH of these Criteria

Exclusion Criteria

You have previously had a stent placed in the lower part of the big vein in your abdomen or in the main vein in your leg.

You do not have a moderate or severe post-traumatic stress (PTS) disorder.

I've had a recent deep vein thrombosis (DVT) in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either endovascular therapy (EVT) or no-EVT, along with optimal PTS care

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with venous clinical severity scores (VCSS) obtained

6 months

Long-term follow-up

Participants enrolled in earlier protocol versions are followed for an extended period to assess long-term outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Stents

Trial Overview The C-TRACT Trial is testing whether using image-guided endovascular therapy (EVT), which includes placing stents inside veins of the leg can reduce severity of PTS and improve quality of life for patients with disabling venous obstructions after a deep vein thrombosis.

How Is the Trial Designed?

Group I: Endovascular Therapy - Intervention Experimental Treatment 1 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

Group II: Non-Endovascular Therapy - Control Active Control 1 Intervention

All subjects will receive optimal PTS care as noted above.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

St. Luke&#39;s Hospital, Kansas City, Missouri

Collaborator

Trials

1

Recruited

250+

Saint Luke's Mid America Heart Institute

Collaborator

Trials

3

Recruited

1,900+

Ontario Clinical Oncology Group (OCOG)

Collaborator

Trials

65

Recruited

42,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Trials

9

Recruited

12,500+

Published Research Related to This Trial

In a study involving 18 patients with post-thrombotic syndrome, both contrast-enhanced MRI (CE-MRI) and non-contrast-enhanced MRI (NCE-MRI) provided similar and clinically insignificant measurements of vein section area, suggesting that NCE-MRI can effectively replace CE-MRI for preoperative evaluations.

However, the study found that measurements from MRI did not correlate well with those obtained from intravascular ultrasound (IVUS), which showed an average difference of 60%, indicating that IVUS remains essential for accurately selecting the appropriate stent size for venous interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of non-contrast-enhanced magnetic resonance imaging prior to venous interventions. Kusiak, A., Budzyński, J.[2022]

Bare-metal stents, while a significant improvement over traditional angioplasty, have a high restenosis rate of about 30%, which can lead to the need for further interventions.

First-generation drug-eluting stents effectively reduce restenosis but are linked to serious late thrombotic events, raising safety concerns; ongoing research aims to develop new stent systems that enhance efficacy while minimizing thrombosis risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative safety of bare-metal and drug-eluting intracoronary stents. Lambert, ND., Applegate, RJ.[2016]

Endovenous stenting for post-thrombotic syndrome (PTS) with iliofemoral obstruction shows a high technical success rate of 95% and significant symptom relief, with ulcer healing in about 75% of cases and pain relief in 52%.

Despite the promising outcomes, the overall quality of evidence is rated as 'very low', indicating that while stenting can be effective and has a low risk of complications, further research is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of Iliofemoral Stenting for Post-thrombotic Syndrome. Qiu, P., Zha, B., Xu, A., et al.[2019]

Vascular stents have advanced from basic devices to complex drug-delivery systems that can be used in various parts of the body, not just the coronary circulation.

These newer generation stents help prevent complications like neointimal hyperplasia and thrombosis while promoting healthy blood vessel growth, leading to safer and more effective long-term treatments for vascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in stent technology and drug-eluting stents. Nelken, N., Schneider, PA.[2005]

In a study of 200 patients treated with a dedicated sinus-Venous stent, significant clinical improvements were observed, with a decrease in the Villalta score from 10.5 to 5.3, indicating reduced symptoms of post-thrombotic syndrome (PTS) and iliac vein compression syndrome (IVCS).

The stent demonstrated promising patency rates, with primary patency at 68% and secondary patency at 90% over a median follow-up of 12 months, while complications were relatively low, suggesting the stent's effectiveness and safety in treating venous obstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patency rates and clinical outcomes in a cohort of 200 patients treated with a dedicated venous stent. van Vuuren, TMAJ., Doganci, S., Wittens, CHA.[2019]

In a study involving 20 patients with malignant venous obstructions, the use of self-expandable metallic stents successfully relieved symptoms in 16 patients, with complete symptom resolution in 8 cases until death from tumor progression.

The stents were effective in maintaining patency for an average follow-up of three months in 8 patients, demonstrating their utility as a palliative treatment option, despite some complications like thrombotic occlusion and stent migration in a few cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stent implantation as a palliative therapeutic measure in tumor-induced stenoses of the large veins of the body]. Wilhelm, K., Schild, H., Bruch, E., et al.[2016]

Metallic stents have significantly improved the treatment of arterial and venous diseases through minimally invasive procedures, enabling the treatment of various lesions that were previously difficult or impossible to address.

The article reviews the different types of stents available, highlighting their role in revolutionizing vascular disease management and enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting in peripheral vascular disease. Cleveland, TJ., Gaines, P.[2019]

Despite advancements in stent technology, including drug-eluting stents, restenosis remains a significant challenge in vascular surgery, indicating that current solutions are not fully effective.

Combining drug-eluting stents with dual antiplatelet therapy has reduced the rates of restenosis and reocclusion, but issues like thrombosis and neointimal hyperplasia still persist in the long term, highlighting the need for further innovations in stent design and drug delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vascular stents: Approaches used to increase their clinical efficacy]. Kuznetsov, KA., Khar'kova, MV., Karpenko, AA., et al.[2018]

Bioresorbable scaffolds offer a temporary support for blood vessels, gradually dissolving to reduce the risk of long-term complications associated with permanent metal implants.

These scaffolds are designed to release drugs in a controlled manner, initially providing a high concentration to prevent vascular injuries and excessive tissue growth, which can help in treating conditions like restenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioresorbable Scaffold-Based Controlled Drug Delivery for Restenosis. Tesfamariam, B.[2020]

A systematic review of 56 studies involving venous stenting for deep venous obstructions showed a primary patency rate of 82.3% at one year, which decreased to 73.3% at two years, indicating that while stenting is effective, long-term success can be challenging.

Most studies utilized vitamin K antagonists for antithrombotic therapy, but only two studies directly evaluated the impact of this therapy on stent patency, highlighting a significant gap in research regarding the effectiveness of antithrombotic treatments in maintaining stent function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postinterventional antithrombotic management after venous stenting of the iliofemoral tract in acute and chronic thrombosis: A systematic review. Notten, P., Ten Cate, H., Ten Cate-Hoek, AJ.[2023]

The incidence of scaffold thrombosis after bioresorbable vascular scaffold (BVS) implantation was found to be 1.8% at a median follow-up of 1 year, increasing to 0.8% beyond 1 year, indicating a significant risk associated with BVSs over time.

When compared to everolimus-eluting metallic stents (EESs), BVSs showed a 3.4 times higher risk of scaffold thrombosis and also increased risks for myocardial infarction and target lesion revascularization, suggesting that BVSs may not be as safe as EESs in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid- and Long-Term Outcome Comparisons of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents: A Systematic Review and Meta-analysis. Zhang, XL., Zhu, QQ., Kang, LN., et al.[2022]

Surface modification of stainless steel stents with hydrophilic polymers like N-vinylpyrrolidone (NVP) and potassium sulfopropyl acrylate (KSPA) significantly reduces platelet adhesion, which is crucial for preventing blood clots.

In both in vitro and in vivo tests, KSPA-modified stents showed the lowest platelet accumulation, suggesting that this modification could effectively lower the risk of thrombosis in patients using these stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrophilic surface modification of metallic endoluminal stents. Seeger, JM., Ingegno, MD., Bigatan, E., et al.[2019]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.013398

Results of the ACCESS PTS Study Percutaneous transluminal venoplasty and ultrasound‐accelerated thrombolysis resulted in successful recanalization of chronic venous obstruction.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4963268/

Endovascular therapy for advanced post-thrombotic ... Preliminary studies suggest that image-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction (with stent placement) and saphenous ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X24002166

Safety and efficacy of endovenous ablation in patients with ... Endovenous thermal ablation can be safe and effective in patients with a history of DVT; however, an individualized risk/benefit assessment and patient ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10230505/

A Clinical Trial of Venous Stent Placement for Post- ... The primary study hypothesis is that the use of endovascular stent therapy will reduce the severity of PTS at 6 months, assessed by a blinded examiner using the ...

5. cdt.amegroups.org cdt.amegroups.org/article/view/12865/html

Incidence and interventions for post-thrombotic syndrome Several studies have been conducted to assess the patency rates and effectiveness of endovascular management of post-thrombotic venous occlusion disease.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X25000952

Four-year outcomes following endovascular treatment in ... This study aimed to evaluate the safety and efficacy of endovascular treatment for post-thrombotic syndrome (PTS) in the lower extremities.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10378457/

Patient-Reported Outcomes of Endovascular Treatment ... Excellent outcomes of angioplasty/stenting for the post-thrombotic syndrome (PTS) have been reported, notably regarding objective criteria ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073050

Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for ... 100 mg of daily aspirin plus 20 mg of rivaroxaban is superior to 20 mg of rivaroxaban alone to prevent stent thrombosis within 6 months after stent placement ...

9. jvsvenous.org jvsvenous.org/article/S2213-333X(24)00228-2/fulltext

Interventional treatment for post-thrombotic chronic venous ... This review synthesizes current knowledge on the interventional treatment of post-thrombotic syndrome, focusing on the evolution of endovascular techniques and ...

10. qims.amegroups.org qims.amegroups.org/article/view/11204/html

Endovascular stent placement for chronic post-thrombotic ... Conclusions: Our results confirm the high clinical success rate and safety of endovascular PTS treatment and highlight the significant impact of stenting on ...