Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

Thrombosis, Deep Vein Clinical Trial

— DEXTERITY-AFP  

Official title:

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862468
• Other study ID #: CIP0217
• Status: Recruiting
• Phase: Phase 2
• Start date: October 29, 2021
• Est. completion date: July 31, 2027

Study information

• Verified date: August 2023
• Source: Mercator MedSystems, Inc.
• Contact: Kirk Seward, PhD
• Phone: 510-614-4550
• Email: kseward[@]mercatormed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures.

2. Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study.

3. Male or female, aged 18 to 89 years.

4. For females of reproductive potential: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment.

5. Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.

6. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.

7. Post-procedural prescription for at least 28 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12 months minimum as part of post-interventional medication regimen.

8. Minimum of 28 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor) for patients receiving stents.

9. DVT located in any of the major femoropopliteal veins, with possible extension downstream into the iliac veins.

10. Successful recanalization of the target vein with removal of acute thrombus.

Exclusion Criteria:

1. Current enrollment in another non-registry clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study. Concurrent enrollment in registry studies of approved devices or drugs are acceptable.

2. Lack of capability of understanding the nature, significance and implications of the clinical trial.

3. Body Mass Index between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.

4. Body Mass Index > 45 kg/m2.

5. Non-ambulatory status prior to DVT occurrence.

6. In the study leg: current established PTS (Villalta = 5 for more than 14 days), current known symptomatic deep venous insufficiency for more than 14 days, or previous symptomatic DVT within the last 365 days.

7. In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require open or endovascular surgery in the following 30 days.

8. In cases with symptoms of limb-threatening circulatory compromise, ankle-brachial index <0.4, absolute ankle pressure <50 mmHg or absolute toe pressure <30 mmHg.

9. Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.

10. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.

11. Allergy or hypersensitivity to any drugs planned for use in the case (including dexamethasone sodium phosphate, iodinated contrast, low molecular-weight heparin, or recombinant tissue plasminogen activator, rtPA, if planned), except for mild-moderate contrast allergies for which steroid pre-medication can be used.

12. History of, or active heparin-induced thrombocytopenia (HIT).

13. Hemoglobin < 9.0 g/dl.

14. INR > 1.6 before starting anticoagulation.

15. Platelets < 100,000/ml.

16. Severe renal impairment (estimated glomerular filtration rate < 30 ml/min).

17. Active bleeding, recent (< 1 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.

18. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy.

19. Recent (< 10 days) major surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure which, in the Investigator's discretion, could impair follow-up or study outcomes.

20. Obstetrical delivery <72 hours prior to procedure.

21. Hemorrhagic stroke within the last 365 days.

22. Intracranial/intraspinal bleed within the last 365 days.

23. Intracranial/intraspinal tumor within the last 365 days.

24. Intracranial/intraspinal vascular malformation within the last 365 days.

25. Intracranial/intraspinal aneurysm within the last 365 days.

26. Active symptomatic COVID-19 infection that, in the Investigator's discretion, could impair follow-up or study outcomes.

27. Severe hypertension on repeated readings (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure <140 mmHg).

28. Pregnant or breastfeeding.

29. Life expectancy < 2 years (e.g. due to active cancer).

30. Major thrombus of the inferior vena cava (IVC) (occlusive or near-occlusive) extending at least one centimeter above the common iliac confluence.

31. Inability to obtain venous access.

32. Inability to recanalize the target vein segment with less than 30% residual obstruction due to thrombus.

33. History of ipsilateral venous stent.

34. DVT length intended for drug treatment exceeds 50 cm.

Related Conditions & MeSH terms

• Inflammation
• Thrombosis
• Thrombosis, Deep Vein
• Venous Thrombosis

Intervention

Combination Product:
• Perivascular dexamethasone
Dexamethasone delivery around target vein segment(s)
• Perivascular sham
Saline delivery around target vein segment(s)

Locations

Country	Name	City	State
Ireland	Galway University Hospital	Galway
United Kingdom	Guy's and St. Thomas Hospital	London
United States	St John Health System	Bartlesville	Oklahoma
United States	Lake Washington Vascular	Bellevue	Washington
United States	Northwestern University Hospital	Chicago	Illinois
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Vascular Care Connecticut	Darien	Connecticut
United States	CardioVoyage	Denison	Texas
United States	CIS Clinical Research	Houma	Louisiana
United States	University of Texas, Houston	Houston	Texas
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Stony Brook University Hospital	Stony Brook	New York
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mercator MedSystems, Inc.

Countries where clinical trial is conducted

United States,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinically relevant primary patency	Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms	6 months
Primary	Rate of freedom from major adverse event (MAE)	Rate of freedom from composite of all-cause death, clinically significant pulmonary embolism, major bleeding, target vessel thrombosis, infection of treatment or insertion site, or AV fistula of treatment site	30 days