Venous Thrombosis Deep (Limbs)FASTNCT07708376
A Registry of the FLOWRUNNER Aspiration System for Patients With Symptomatic Venous Thrombosis
An observational study of Venous Thrombosis Deep (Limbs) and Venous Thrombosis, run by FlowPhysix, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis Deep (Limbs), Venous Thrombosis
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 30 Nov 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)
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.
Read the 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.
- Conditions
- Venous Thrombosis Deep (Limbs), Venous Thrombosis
- Being tested
- Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
- Keywords
- Removal of Symptomatic Venous Thrombosis, Symptomatic Venous Thrombosis, Thrombosis, Thrombectomy, Blood Clot
- Medical subject headings
- Venous Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Thrombectomy - Standard of Care procedure for venous thrombosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic upper- or lower-extremity venous thrombosis | The study is an observational registry to collect data on the standard of care treatment of venous thrombosis. There is no investigational intervention. All participants will receive mechanical thrombectomy as standard of care. Receives: Other: Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
The number of patients that had a response to treatment after the standard of care mechanical thrombectomy procedure with the study device, defined as removal of thrombus (a large amount of the blood clot from the vein or artery) during the study procedure.
Measured: Immediately Post Procedure
Safety Events will measure any risks that may occur during or after the study procedure
The number of patients that have serious problems after the standard of care mechanical thrombectomy procedure that could be life threatening or cause major harm.
Measured: Within 30 days of the study procedure
Procedure Results
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
Measured: Immediately after the study procedure
Secondary outcomes (4)
Vein Patency
The number of patients that have vein patency as measured by duplex ultrasound or other imaging.
Measured: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Vein Disability Score
The number of patients that have improvement in Vein Disability Score which is a clinical assessment by the physician to score how chronic venous disease affects a patient's mobility and daily functionality. A score of 0 means no symptoms and a score of 3 means severe disability.
The total score per follow up visit will be compared to baseline.
Measured: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Villalta Score
The number of patients that have improvement in Villalta Score which is a clinical assessment by the physician to score patient reported symptoms from a score of 0 to 3 based on severity. A score of 0 indicates absence of symptoms and a score of 3 indicates severe symptoms. The total score is the sum of all individual scores. 0-4 is no symptoms to >15 is severe symptoms.
Clinical signs will be scored by the physician or nurse after physical examination of the affected arm/leg.
Measured: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Quality of Life
The number of patients that have an improvement of Quality of Life as measured by the EuroQol Questionnaire. It evaluates 5 dimensions of health, with 5 levels of severity for each. A score of 1 for each question is good health, a score of 5 for each question is poor health.
Measured: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Venous Thrombosis Deep (Limbs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 218 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- FlowPhysix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708376
- Sponsor's protocol ID
- CLPF079-01
- Acronym
- FAST
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 2023 Aug 12.
PubMed 37573936Bauersachs 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.
PubMed 34210599Toma 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.
PubMed 36349702Bisharat 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 Mar.
PubMed 39131784Dexter 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.2023.100585. eCollection 2023 Mar-Apr.
PubMed 39129803Kahn 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.
PubMed 19320818Mittleider 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.
PubMed 39166156Avgerinos 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.
PubMed 26993678Robertson B, Neville E, Muck A, Broering M, Kulwicki A, Kuhn B, Recht M, Muck P. Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device. J Vasc Surg Venous Lymphat Disord. 2022 May;10(3):594-601. doi: 10.1016/j.jvsv.2021.11.002. Epub 2021 Nov 23.
PubMed 34823046Lopez R, DeMartino R, Fleming M, Bjarnason H, Neisen M. Aspiration thrombectomy for acute iliofemoral or central deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):162-168. doi: 10.1016/j.jvsv.2018.09.015. Epub 2019 Jan 10.
PubMed 30639411Enden T, Haig Y, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13.
PubMed 22172244Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
PubMed 26853645Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.
PubMed 29211671Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.
PubMed 26867832Kohi MP, Kohlbrenner R, Kolli KP, Lehrman E, Taylor AG, Fidelman N. Catheter directed interventions for acute deep vein thrombosis. Cardiovasc Diagn Ther. 2016 Dec;6(6):599-611. doi: 10.21037/cdt.2016.11.20.
PubMed 28123980
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)
- ClinicalTrials.gov ID
- NCT07708376
- Acronym / sponsor ID
- FAST / CLPF079-01
- Conditions
- Venous Thrombosis Deep (Limbs), Venous Thrombosis
- Keywords
- Removal of Symptomatic Venous Thrombosis, Symptomatic Venous Thrombosis, Thrombosis, Thrombectomy, Blood Clot
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- FlowPhysix, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic upper- or lower-extremity venous thrombosis | – | Other: Mechanical Thrombectomy - Standard of Care procedure for venous thrombosisThe study is an observational registry to collect data on the standard of care treatment of venous thrombosis. There is no investigational intervention. All participants will receive mechanical thrombectomy as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
Key inclusion criteria (0 listed)
Key exclusion criteria (35 listed)
- 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:
- Presents with cardiogenic shock or is hemodynamically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Thrombectomy - Standard of Care procedure for venous thrombosisParticipant 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. | Other | Symptomatic upper- or lower-extremity venous thrombosis |
Primary outcome
Procedure Success
Time frame: Immediately Post Procedure
The number of patients that had a response to treatment after the standard of care mechanical thrombectomy procedure with the study device, defined as removal of thrombus (a large amount of the blood clot from the vein or artery) during the study 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
The number of patients that have serious problems after the standard of care mechanical thrombectomy procedure that could be life threatening or cause major harm.
Procedure Results
Time frame: Immediately after the study procedure
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 37573936Rabe 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 2023 Aug 12.
- Background: PubMed 34210599Bauersachs 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.
- Background: PubMed 36349702Toma 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.
- Background: PubMed 39131784Bisharat 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 Mar.
- Background: PubMed 39129803Dexter 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.2023.100585. eCollection 2023 Mar-Apr.
- Background: PubMed 19320818Kahn 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.
- Background: PubMed 39166156Mittleider 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.
- Background: PubMed 26993678Avgerinos 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.
- Background: PubMed 34823046Robertson B, Neville E, Muck A, Broering M, Kulwicki A, Kuhn B, Recht M, Muck P. Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device. J Vasc Surg Venous Lymphat Disord. 2022 May;10(3):594-601. doi: 10.1016/j.jvsv.2021.11.002. Epub 2021 Nov 23.
- Background: PubMed 30639411Lopez R, DeMartino R, Fleming M, Bjarnason H, Neisen M. Aspiration thrombectomy for acute iliofemoral or central deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):162-168. doi: 10.1016/j.jvsv.2018.09.015. Epub 2019 Jan 10.
- Background: PubMed 22172244Enden T, Haig Y, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13.
- Background: PubMed 26853645Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis Deep (Limbs) and Venous Thrombosis, run by FlowPhysix, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prasad Nalluri (210-355-9512, prasad.nalluri@flowphysix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: Immediately Post Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07708376, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.