Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)

• ClinicalTrials.gov Identifier: NCT04858776
• Recruitment Status: Recruiting
• First Posted: April 26, 2021
• Last Update Posted: October 18, 2023
• Sponsor: Mercator MedSystems, Inc.
• Information provided by (Responsible Party): Mercator MedSystems, Inc.

Study Description

Brief 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 at least 14 days and no more than 60 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.

Condition or disease	Intervention/treatment	Phase
Iliofemoral; Thrombosis	Combination Product: Perivascular dexamethasone; Combination Product: Perivascular sham	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
• Actual Study Start Date: August 8, 2022
• Estimated Primary Completion Date: May 31, 2025
• Estimated Study Completion Date: December 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment	Combination Product: Perivascular dexamethasone; Dexamethasone delivery around target vein segment(s)
Sham Comparator: Control	Combination Product: Perivascular sham; Saline delivery around target vein segment(s)

Outcome Measures

Primary Outcome Measures :

1. Clinically relevant primary patency [ Time Frame: 6 months ]
   Freedom from loss of patency with associated symptoms
2. Freedom from major adverse event (MAE) [ Time Frame: 30 days ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation.
5. Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months.
6. Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the iliofemoral segment.
7. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
8. Prescription for at least 14 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12-month minimum as part of post-interventional medication regimen.
9. Minimum of 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor).
10. Hemodynamically significant DVT (>50% area obstruction) spanning at least (a) the iliofemoral and common femoral veins or (b) the common femoral vein with extension into the femoral vein and/or profunda vein. Extent of thrombus in the popliteal and calf veins is allowed.
11. Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda).

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 > 40 kg/m2.
4. Non-ambulatory status prior to DVT occurrence.
5. In the target vein segment: previously treated symptomatic DVT within the previous 12 months.
6. In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require surgery in the following 30 days.
7. Limb-threatening circulatory compromise with ankle-brachial index <0.4, absolute ankle pressure <50 mmHg or absolute toe pressure <30 mmHg.
8. 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.
9. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
10. Allergy, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue plasminogen activator (rtPA), dexamethasone sodium phosphate or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
11. History of, or active heparin-induced thrombocytopenia (HIT).
12. Haemoglobin < 9.0 mg/dl, INR > 1.6 before starting anticoagulation, or platelets < 100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular filtration rate < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated glomerular filtration rate < 30 ml/min).
13. Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
14. Recent (< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.
15. History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
16. Active cancer with a life expectancy of <2 years.
17. 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).
18. Pregnant or breastfeeding.
19. Life expectancy < 2 years.
20. Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac confluence.
21. Inability to obtain venous access.
22. Inability to recanalize the target vein segment(s).
23. History of ipsilateral venous stent.
24. DVT length to be targeted for perivascular drug therapy exceeds 50 cm.

Contacts and Locations

Contacts

Contact: Kirk Seward, PhD; 510-614-4550; kseward@mercatormed.com

Locations

United States, Connecticut

Vascular Care Connecticut; Recruiting

Darien, Connecticut, United States, 06820

United States, Florida

University of South Florida; Recruiting

Tampa, Florida, United States, 33060

United States, Illinois

Northwestern University Hospital; Recruiting

Chicago, Illinois, United States, 60611

United States, Louisiana

CIS Clinical Research; Recruiting

Houma, Louisiana, United States, 70360

United States, Maryland

Medstar Health Research Institute; Recruiting

Hyattsville, Maryland, United States, 20782

United States, New York

Stony Brook University Hospital; Not yet recruiting

Stony Brook, New York, United States, 11794

United States, North Carolina

NC Heart and Vascular Research; Recruiting

Raleigh, North Carolina, United States, 27607

United States, Ohio

OhioHealth Research Institute; Recruiting

Columbus, Ohio, United States, 43214

United States, Oklahoma

St John Health System; Recruiting

Bartlesville, Oklahoma, United States, 74006

United States, Texas

CardioVoyage; Recruiting

Denison, Texas, United States, 75020

University of Texas, Houston; Recruiting

Houston, Texas, United States, 77494

United States, Virginia

Sentara Norfolk General Hospital; Recruiting

Norfolk, Virginia, United States, 23452

United States, Washington

Lake Washington Vascular; Recruiting

Bellevue, Washington, United States, 98004

Ireland

Galway University Hospital; Recruiting

Galway, Ireland, H91 YR71

United Kingdom

Guy's and St. Thomas Hospital; Recruiting

London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Mercator MedSystems, Inc.

More Information

• Responsible Party: Mercator MedSystems, Inc.
• ClinicalTrials.gov Identifier: NCT04858776
• Other Study ID Numbers: CIP0218
• First Posted: April 26, 2021
• Last Update Posted: October 18, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Thrombosis; Inflammation; Pathologic Processes; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents