- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858776
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
October 17, 2023 updated by: Mercator MedSystems, Inc.
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kirk Seward, PhD
- Phone Number: 510-614-4550
- Email: kseward@mercatormed.com
Study Locations
-
-
-
Galway, Ireland, H91 YR71
- Recruiting
- Galway University Hospital
-
-
-
-
-
London, United Kingdom, SE1 7EH
- Recruiting
- Guy's and St. Thomas Hospital
-
-
-
-
Connecticut
-
Darien, Connecticut, United States, 06820
- Recruiting
- Vascular Care Connecticut
-
-
Florida
-
Tampa, Florida, United States, 33060
- Recruiting
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University Hospital
-
-
Louisiana
-
Houma, Louisiana, United States, 70360
- Recruiting
- CIS Clinical Research
-
-
Maryland
-
Hyattsville, Maryland, United States, 20782
- Recruiting
- MedStar Health Research Institute
-
-
New York
-
Stony Brook, New York, United States, 11794
- Not yet recruiting
- Stony Brook University Hospital
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27607
- Recruiting
- NC Heart and Vascular Research
-
-
Ohio
-
Columbus, Ohio, United States, 43214
- Recruiting
- OhioHealth Research Institute
-
-
Oklahoma
-
Bartlesville, Oklahoma, United States, 74006
- Recruiting
- St John Health System
-
-
Texas
-
Denison, Texas, United States, 75020
- Recruiting
- CardioVoyage
-
Houston, Texas, United States, 77494
- Recruiting
- University of Texas, Houston
-
-
Virginia
-
Norfolk, Virginia, United States, 23452
- Recruiting
- Sentara Norfolk General Hospital
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Recruiting
- Lake Washington Vascular
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures.
- Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study.
- Male or female, aged 18 to 89 years.
- 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.
- Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months.
- Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the iliofemoral segment.
- Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
- 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.
- Minimum of 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor).
- 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.
- Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda).
Exclusion Criteria:
- 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.
- Lack of capability of understanding the nature, significance and implications of the clinical trial.
- Body Mass Index > 40 kg/m2.
- Non-ambulatory status prior to DVT occurrence.
- In the target vein segment: previously treated symptomatic DVT within the previous 12 months.
- In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require surgery in the following 30 days.
- Limb-threatening circulatory compromise with ankle-brachial index <0.4, absolute ankle pressure <50 mmHg or absolute toe pressure <30 mmHg.
- 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.
- Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
- 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.
- History of, or active heparin-induced thrombocytopenia (HIT).
- 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).
- Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
- 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.
- History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Active cancer with a life expectancy of <2 years.
- 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).
- Pregnant or breastfeeding.
- Life expectancy < 2 years.
- Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac confluence.
- Inability to obtain venous access.
- Inability to recanalize the target vein segment(s).
- History of ipsilateral venous stent.
- DVT length to be targeted for perivascular drug therapy exceeds 50 cm.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control
|
Saline delivery around target vein segment(s)
|
Experimental: Treatment
|
Dexamethasone delivery around target vein segment(s)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically relevant primary patency
Time Frame: 6 months
|
Freedom from loss of patency with associated symptoms
|
6 months
|
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
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2022
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 21, 2021
First Submitted That Met QC Criteria
April 21, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Inflammation
- Thrombosis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- CIP0218
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iliofemoral; Thrombosis
-
Abdelrahman Ibrahim Sayed Mohamed AbdallaNot yet recruitingIliofemoral Deep Vein Thrombosis
-
Mercator MedSystems, Inc.University of South Florida; Northwestern University; Stony Brook University; Guy... and other collaboratorsRecruitingThrombosis, Deep Vein | Iliofemoral; ThrombosisUnited States, Ireland, United Kingdom
-
Medtronic EndovascularCompletedIliofemoral Venous ObstructionUnited States, France, Germany, United Kingdom, Ireland, Italy
-
Cook Group IncorporatedCompletedIliofemoral Venous Outflow ObstructionSwitzerland, United Kingdom, Ireland, Germany, Spain
-
Cook Research IncorporatedCompletedSymptomatic Venous Outflow Obstruction in the Iliofemoral VeinUnited States, Taiwan
-
Boston Scientific CorporationCompletedChronic Venous Disorder | Venous Outflow Obstruction | Symptomatic Venous Outflow Obstruction of Iliofemoral VeinUnited States, Ireland, United Kingdom, Netherlands, France, Germany, Spain
-
Boston Scientific CorporationWithdrawnChronic Venous Disorder | Venous Outflow Obstruction | Systemic Vein Outflow of Iliofemoral Vein
-
The Second Hospital of QinhuangdaoCompletedShock | Iliofemoral Artery Injury
-
Università degli Studi dell'InsubriaOttawa Hospital Research InstituteUnknownPortal Vein Thrombosis | Mesenteric Vein Thrombosis | Splenic Vein ThrombosisCanada, Italy
-
University of MaltaUniversità degli Studi dell'InsubriaRecruitingCerebral Vein Thrombosis | Renal Vein Thrombosis | Retinal Vein Thrombosis | Splanchnic Vein Thrombosis | Ovarian Vein ThrombosisThailand, Spain, United States, Italy, Slovenia, France, Israel, Canada, Malta, Netherlands
Clinical Trials on Perivascular dexamethasone
-
Mercator MedSystems, Inc.University of South Florida; Northwestern University; Stony Brook University; Guy... and other collaboratorsRecruitingThrombosis, Deep Vein | Iliofemoral; ThrombosisUnited States, Ireland, United Kingdom
-
VenoStentActive, not recruitingVascular Diseases | Urologic Diseases | Chronic Kidney Diseases | Renal Insufficiency | Renal Failure | End Stage Renal Disease | Hemodialysis Access Failure | Fistula | Arteriovenous Malformations | Vascular Malformations | End Stage Kidney Disease | Arteriovenous Fistula | Renal Failure Chronic | Vascular Fistula | Catheter Complications and other conditionsParaguay
-
VenoStentRecruitingChronic Kidney Diseases | Renal Insufficiency | Renal Failure | End Stage Renal Disease | Hemodialysis Access Failure | ESRD | Arteriovenous Fistula | Vascular Access Complication | Catheter Complications | Catheter DysfunctionUnited States
-
Helios Research CenterCompleted
-
Antonios LikourezosCompletedLeiomyoma | Laparoscopy | Uterine MyomectomyUnited States
-
Beijing Tsinghua Chang Gung HospitalPeking University People's HospitalNot yet recruitingAcute Ischemic Stroke | Functional Outcomes
-
Ottawa Hospital Research InstituteCompletedPain Syndrome | Early-stage Breast CancerCanada
-
Centre hospitalier de l'Université de Montréal...CompletedPrevention of Hypersensitivity Reactions to PaclitaxelCanada
-
Universidade Federal de PernambucoCompletedDiabetic Macular EdemaBrazil
-
Shanghai Jiao Tong University Affiliated Sixth...CompletedAnalgesia | Time | Brachial Plexus Block | Shoulder Surgery | Dexamethasone | Intravenous Drug UsageChina