Acute Deep Venous Thrombosis of Femoral Vein (Disorder)PREFERNCT05588284
Preservation of Venous Valvular Function After PMT for Acute DVT
A study testing AngioJet device and anticoagulation alone in people with Acute Deep Venous Thrombosis of Femoral Vein (Disorder), run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 7 sites in China.
Trial summary
To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Deep Venous Thrombosis of Femoral Vein (Disorder)
- What is being tested?
- AngioJet device and anticoagulation alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesChina
- Study dates
- 6 Jun 2022to 30 Dec 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).
Who cannot join
- Participants were excluded if they had symptoms for more than 14 days.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Chuzhou People's Hospital
Chuzhou, Anhui, 238000
Center hospital of Putu
Shanghai, Shanghai Municipality, 200011
Central Hospital of Songjiang
Shanghai, Shanghai Municipality, 200011
North Branch of Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
Fengchen Hospital
Shanghai, Shanghai Municipality, 201400
Taizhou Municipal hospital
Taizhou, Zhejiang, 218000
About this study
Official title: Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study
To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.
Read the detailed description
All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.
- Being tested
- AngioJet device, anticoagulation alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioJet deviceDevice
Also called Zalente
A device can be used for thrombus aspiration and thrombolysis.
anticoagulation aloneOther
Also called rivaroxaban
a medicine for anticoagulation therapy
| Study group | Role | What they receive |
|---|---|---|
| Pharmacomechanical Catheter-directed Thrombolysis for acute DVT | Experimental | AngioJet, Boston Scientific Receives: Device: AngioJet device |
| anticoagulation alone for acute DVT | Placebo comparator | anticoagulation alone for acute DVT Receives: Other: anticoagulation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valvular reflux prevalence
Proportion of patients with femoral venous valve reflux at 1 year after procedure
Measured: at 12 months after procedure
Secondary outcomes (2)
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Patients who experienced one of the following occurrences in the index leg between the 12 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Measured: at 6, 12 and 24 months after procedure
Patency rate of femopopliteal vein and iliofemoral vein
Patients who presented with patent femopopliteal vein and iliofemoral vein
Measured: at 6, 12 and 24 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start6 Jun 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Deep Venous Thrombosis of Femoral Vein (Disorder)Studies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Kaichuang Ye, MD, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588284
- Sponsor's protocol ID
- AAL03
- Acronym
- PREFER
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05588284
- Acronym / sponsor ID
- PREFER / AAL03
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Oct 2022 (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.
To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.
Detailed description
All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacomechanical Catheter-directed Thrombolysis for acute DVT | Experimental | Device: AngioJet deviceAngioJet, Boston Scientific |
| anticoagulation alone for acute DVT | Placebo comparator | Other: anticoagulation aloneanticoagulation alone for acute DVT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).
Key exclusion criteria (1 listed)
- Participants were excluded if they had symptoms for more than 14 days.
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 |
|---|---|---|
| AngioJet deviceAlso: ZalenteA device can be used for thrombus aspiration and thrombolysis. | Device | Pharmacomechanical Catheter-directed Thrombolysis for acute DVT |
| anticoagulation aloneAlso: rivaroxabana medicine for anticoagulation therapy | Other | anticoagulation alone for acute DVT |
Primary outcome
Valvular reflux prevalence
Time frame: at 12 months after procedure
Proportion of patients with femoral venous valve reflux at 1 year after procedure
2 secondary outcomes
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Time frame: at 6, 12 and 24 months after procedure
Patency rate of femopopliteal vein and iliofemoral vein
Time frame: at 6, 12 and 24 months after 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 5 May 2026.
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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.
Kaichuang Ye, MD, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioJet device and anticoagulation alone in people with Acute Deep Venous Thrombosis of Femoral Vein (Disorder), run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 7 sites in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valvular reflux prevalence (time frame: at 12 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.