Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems

Thrombosis, Venous Clinical Trial

— ASTER  

Official title:

Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems in a Monocentric, Observational Retrospective and Prospective Study (ASTER Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288906
• Other study ID #: ASTER Study
• Status: Not yet recruiting
• Start date: March 30, 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient admitted in Unit of Vascular Surgery, San Raffaele Hospital, Milan

• Patients able to sign specific informed consent for the study

• Age 18 years to 75 years

• Proximal DVT (inferior vena cava, iliac vein, common femoral vein, deep femoral vein, and femoral vein) that was objectively diagnosed with CT scan

• Symptomatic DVT (pain, neurological deficit) or imparement of the tissue perfusion (phlegmasia)

• Diagnosis of the DVT since 1 month prior to the index procedure

Exclusion Criteria:

• Patient treated with mechanical thrombectomy in the two week prior to the index procedure

• Patient treated with thrombolysis drugs within 48 hours prior to the index procedure

• Life expectancy less than (<) 1 year

• Body Mass Index (BMI) greater than (>) 40 kilograms/square meter (kg/m^2) or per Investigator's discretion participant is able tolerate the procedure and be compliant with post-procedure increased physical activity.

• Active bleeding, recent (<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis

• Recent (<3 months) internal eye surgery or hemorrhagic retinopathy; recent (<10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR), obstetrical delivery, or other invasive procedure

• History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, or aneurysm

• Active cancer (metastatic, progressive, or treated within the last 6 months). Participants with non-melanoma primary skin cancers are eligible to participate in the study

• Hemoglobin <9.0 milligrams/deciliter (mg/dL) within 24 hours prior to the procedure

• International normalized ratio (INR) =1.5 nanograms/deciliter (ng/dL) within 24 hours prior to the procedure

• Platelet count <100,000 cells/cubic millimeter (cells/mm^3) or >700,000 cells/mm^3 within 24 hours prior to the procedure

• Creatinine outside the normal range for the treating institution and considered clinically significant by the Investigator

• Uncontrolled hypertension, defined as systolic >175 millimeters of mercury (mmHg) and a diastolic >110 mmHg

• Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug within 7 days of the study procedure

• In the judgment of the clinician, the participant is at high risk for catastrophic bleeding

• Impossibility or refusal to give informed consent

Related Conditions & MeSH terms

• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

Other:
• mechanical thrombectomy of caval and iliofemoral veins
investigate efficacy, safety of mechanical thrombectomy systems used in symptomatic acute and subacute ileofemoral and caval thrombosis

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Abramowitz S, Bunte MC, Maldonado TS, Skripochnik E, Gandhi S, Mouawad NJ, Mojibian H, Schor J, Dexter DJ; CLOUT study collaborators. Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein — View Citation

Jolly MA, Lockhart MM, Shah D, Huff CM, Valenti EA, Phillips JA, Bittar S, Botti CF, Kolluri R, Silver MJ. Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. J Vasc Surg Venous Ly — View Citation

Shaikh A, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Raskin A, Ichinose E, Abramowitz S, Lindquist J, Azene E, Shah N, Nguyen J, Cockrell J, Khalsa B, Khetarpaul V, Murrey DA Jr, Veerina K, Skripochnik E, Maldonado TS, Bunte MC, Annambhotla S, Schor J, Kado H, Mojibian H, Dexter D; CLOUT Investigators. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Intervent Radiol. 2023 Nov;46(11):1571-1580. doi: 10.1007/s00270-023-03509-8. Epub 2023 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Technical success	restore of vein patency with thrombus removal	end of the surgical procedure
Primary	Number of Participants presenting Bleeding	Freedom from Major Bleeding	72 hours of mechanical thrombectomy treatment