A Registry of the FLOWRUNNER Aspiration System for Patients With Symptomatic Venous Thrombosis

Official title

Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)

Overview

The objective of this study is to evaluate how well and how safe the FLOWRUNNER Aspiration System works for treating blood clots in the arms or legs in real-life medical settings.

Detailed description

The study is a registry to collect data from standard of care mechanical thrombectomy procedure using FLOWRUNNER Aspiration System. The FLOWRUNNER Aspiration System is a single use catheter based system indicated for the removal of fresh, soft emboli (a soft clot) and thrombi (a stationary clot) from vessels of the peripheral (in the arms and legs) and venous (blood vessels responsible for carrying deoxygenated blood back to your heart and lungs) system.

Interventions

• Other Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
  Participant will receive mechanical thrombectomy for venous thrombosis as standard of care. This study is an observational registry to collect data on the standard of care non investigational intervention.

Primary outcome measures

• Procedure Success [Time frame: Immediately Post Procedure]
• Safety Events will measure any risks that may occur during or after the study procedure [Time frame: Within 30 days of the study procedure]
• Procedure Results [Time frame: Immediately after the study procedure]

Secondary outcome measures (4)

• Vein Patency [Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.]
• Vein Disability Score [Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure]
• Villalta Score [Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure]
• Quality of Life [Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.]

Eligibility criteria

Eligibility Criteria:

• Adults ≥ 18 years of age.
• Symptomatic upper- or lower-extremity venous thrombosis.
• Treatment with the FLOWRUNNER Aspiration System for venous thrombectomy as part of routine care.
• Willing to participate, able to understand and able to voluntarily sign the Informed Consent Form (ICF) prior to the initial qualifying procedure (index procedure).
• Willing and able to participate and comply with all protocol-required follow-up visits and assessments.

Exclusion criteria

• Evidence of a chronic or previously undiagnosed extensive clot on the pre-procedure venogram that makes endovascular thrombectomy inappropriate. Indicators of chronic clot include significant venous narrowing, the presence of diffuse collateral vessels, partial recanalization, Inferior Vena Cava (IVC) hyperplasia, or other congenital anatomic anomalies of the IVC, iliac veins, or subclavian veins.
• No available upper- or lower-extremity venous access site suitable for the procedure due to absence of appropriate access, severe anatomical obstruction, scarring, or prior surgical alteration that prevents safe catheter insertion or any condition that, in the investigator's judgement, makes upper- or lower-extremity venous access technically infeasible or unsafe.
• Pregnant or breastfeeding at the time of enrollment.
• High-risk for pulmonary embolism (PE), defined as those presenting with:

• Hemodynamic instability (e.g., sustained hypotension, shock, or cardiac arrest)
• Requirement for thrombolytic therapy or surgical embolectomy
• Any condition that, in the investigator's judgment, would pose an unacceptable risk for participation in the study
• Presents with cardiogenic shock or is hemodynamically unstable.
• Any prior or current cancer diagnosis that, in the investigator's judgment, would pose an unacceptable risk or confound study outcomes including but not limited to:

• Tumor-associated venous thrombosis, defined as: venous thrombosis occurring in the context of active malignancy or cancer-related hypercoagulability
• Presence of metastatic disease or ongoing chemotherapy
• Known antiphospholipid syndrome or other high-risk coagulation disorders, including:

• Confirmed diagnosis of antiphospholipid antibody syndrome
• Severe inherited or acquired thrombophilia (e.g., protein C or S deficiency, antithrombin deficiency)
• Any coagulation disorder that, in the investigator's judgment, would pose an unacceptable risk for thrombectomy or confound study outcomes
• Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators.
• Chronic non-ambulatory status, defined as:

• Persistent inability to walk or perform basic mobility activities due to underlying medical conditions
• Conditions such as advanced neurological disease, severe musculoskeletal impairment, or long-term paralysis
• Contraindicated for intravascular therapy including:

• Active bleeding
• Severe anemia with hemoglobin (Hb) < 8 g/dL
• High risk of bleeding
• History of heparin allergy/hypersensitivity or heparin-induced thrombocytopenia
• Hypersensitivity to contrast agents
• Contraindication to oral/intravenous anticoagulation
• Hypercoagulable risk
• Any other condition that cannot be effectively managed
• Renal dysfunction (eGFR < 30 mL/min/1.73m2, not yet on dialysis).
• Cerebral or myocardial infarction in the last 3 months.
• Any condition that, in the investigator's judgment, would pose unacceptable risk or interfere with study participation, including:

• Severe allergy to contrast media
• Active systemic infection
• Uncontrolled coagulopathy
• Phlegmasia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Rabe E, Hoffmann U, Schimke A, Heinken A, Langer F, Noppeney T, Pittrow D, Klotsche J, Gerlach HE, Bauersachs R; INSIGHTS-SVT Study Collaborators. Determinants of Late Venous Thromboembolic Events After Acute Isolated Superficial Vein Thrombosis in Daily Practice: 12 Month Results of the INSIGHTS-SVT Study. Eur J Vasc Endovasc Surg. 2023 Nov;66(5):697-704. doi: 10.1016/j.ejvs.2023.08.031. Epub 202 PMID 37573936
• Bauersachs R, Gerlach HE, Heinken A, Hoffmann U, Langer F, Noppeney T, Pittrow D, Klotsche J, Rabe E. Management and Outcomes of Patients with Isolated Superficial Vein Thrombosis under Real Life Conditions (INSIGHTS-SVT). Eur J Vasc Endovasc Surg. 2021 Aug;62(2):241-249. doi: 10.1016/j.ejvs.2021.04.015. Epub 2021 Jun 29. PMID 34210599
• Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandhar S, Stegman B, Gondi S, Chambers J, Amin R, Leung DA, Kado H, Brown MA, Sarosi MG, Bhat AP, Castle J, Savin M, Siskin G, Rosenberg M, Fanola C, Horowitz JM, Pollak JS. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732. PMID 36349702
• Bisharat MB, Ichinose EJ, Veerina KK, Khetarpaul V, Azene EM, Plotnik AN, Hnath J, Trestman E, Harlin SA, Bhat A, Li S, Long GW, O'Connor D, Winokur RS, Zia S, Dexter DJ. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. J Soc Cardiovasc Angiogr Interv. 2024 Feb 15;3(3Part A):101307. doi: 10.1016/j.jscai.2024.101307. eCollection 2024 PMID 39131784
• Dexter D, Kado H, Shaikh A, Schor J, Annambhotla S, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Bunte MC, Maldonado T, Skripochnik E, Raskin A, Gandhi S, Ichinose E, Beasley R, Mojibian H. Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry. J Soc Cardiovasc Angiogr Interv. 2023 Feb 23;2(2):100585. doi: 10.1016/j.jscai.2023.1005 PMID 39129803
• Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost. 2009 May;7(5):884-8. doi: 10.1111/j.1538-7836.2009.03339.x. Epub 2009 Mar 6. PMID 19320818
• Mittleider D, Gibson CM, Dexter D. Outcomes From Mechanical Thrombectomy for Deep Vein Thrombosis: Insights From the PINC AI Healthcare Database. J Soc Cardiovasc Angiogr Interv. 2024 Jul 25;3(8):102149. doi: 10.1016/j.jscai.2024.102149. eCollection 2024 Aug. PMID 39166156
• Avgerinos ED, Hager ES, Naddaf A, Dillavou E, Singh M, Chaer RA. Outcomes and predictors of failure of thrombolysis for iliofemoral deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):35-41. doi: 10.1016/j.jvsv.2014.07.007. Epub 2014 Aug 22. PMID 26993678

Identifiers

NCT: NCT07708376 · CLPF079-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗