Deep Vein ThrombosisNCT07622199
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
A study testing Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC) and Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) in people with Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.
Trial summary
Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC) and Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2026to 31 Dec 2029
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 85 years;
- Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography);
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patient receives endovascular treatment with rapid endovascular thrombus removal device;
- Patient provides written informed consent.
Who cannot join
- Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;
- Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
- Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;
- Concomitant severe renal insufficiency with creatinine clearance < 30 ml/min;
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- Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders;
- Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or thrombocytopenia (platelet count < 80,000/mL);
- History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
- Pregnancy;
- Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy < 24 months;
- Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study;
- Unwillingness to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji hospital
Shanghai
Qihong Ni, +8615801900772, niqihong1989@163.com
About this study
Official title: PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis: a Multicenter Randomized Controlled Study (The PROTECT Study)
Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.
Read the detailed description
Acute lower extremity deep vein thrombosis (DVT) can lead to obstruction of veins, causing sudden lower limb swelling. Patients may also develop post-thrombotic syndrome (PTS) manifesting as recurrent lower limb swelling, skin disorders, and even non-healing ulcers, which severely affects the patient's quality of life. Among lower extremity DVT, thrombosis involving the iliofemoral veins is the most severe, with an incidence of PTS as high as 20%-50%. According to the results of a prospective clinical study, rapid endovascular thrombus removal can effectively improve the primary thrombus clearance rate and shorten hospital stay in patients with DVT. Among 329 patients, 192 (58.5%) achieved complete thrombus removal using the AngioJet catheter. This therapy was once considered to be the first-line treatment option for DVT. However, the results of the ATTRACT study, published in 2017 in New England Journal of Medicine found that there was no significant difference in the incidence of PTS at two years after pharmacomechanical catheter directed thrombolysis (PCDT) compared with anticoagulation alone. Although PCDT can rapidly remove thrombus, is it unable to improve the long-term outcomes for patients with DVT? According to previous studies, the primary patency rate at 12 months after PCDT for acute iliofemoral venous thrombosis ranges from 77% to 85%, while the incidence of PTS at 24 months postoperatively is as high as 40%. Residual thrombus is an important cause of thrombus recurrence, re-occlusion of the vein, and poor clinical outcomes. Previous studies have primarily focused on thrombus clearance in the popliteal vein, superficial femoral vein, common femoral vein, and iliac vein, while neglecting the assessment and clearance of profunda femoris vein (PFV) thrombosis. As the PFV is an important inflow of the iliofemoral vein, whether PFV-TC can improve the patency rate and clinical outcomes of endovascular treatment for acute iliofemoral DVT remains unclear. In a preliminary study, the investigators analyzed and compared two cohorts: one receiving conventional endovascular treatment for acute iliofemoral venous thrombosis, and the other receiving conventional treatment combined with profunda femoris vein thrombosis clearance (PFV-TC). The results showed that the 24-month patency rate of the iliofemoral vein was 90% vs. 72%, and the incidence of PTS was 11% vs. 32% (P=0.020). These findings were published in November 2025 in European Journal of Vascular and Endovascular Surgery. This study has garnered widespread attention, and de Wolf MAF published an invited commentary on this study, acknowledging the value of this approach in the endovascular treatment of acute iliofemoral DVT. Therefore, the investigators hypothesize that PFV-TC can improve inflow and reduce the incidence of PTS for iliofemoral DVT. However, high-level evidence is still lacking. The PROTECT study is a prospective, multicentre, randomised, open-label, outcome assessor-blinded, 1:1 parallel-group controlled clinical trial evaluating the efficacy and safety of PFV-TC in patients with acute iliofemoral DVT and PFV involvement, which aims to determine whether PFV-TC can reduce the incidence of PTS and provide clinical decision-making in this specific population.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC), Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)
- Keywords
- Deep venous thrombosis, Endovascular treatment, Profunda femoral vein, Post-thrombotic syndrome
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC)Procedure or surgery
Endovascular treatment with PFV-TC group (experimental group): Based on the control group, access is obtained via the contralateral common femoral vein using a crossover technique, or via a popliteal-profunda communicating vessel approach to PFV. The thrombus status of the PFV is assessed, and rapid thrombus removal is performed on the PFV thrombosis.
Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)Procedure or surgery
An appropriate puncture approach is selected, including the ipsilateral calf vein, ipsilateral popliteal vein, or ipsilateral femoral vein. Under ultrasound guidance, a vascular sheath is inserted after puncture, and systemic heparinization is performed. Using a guidewire and catheter, the guidewire is advanced antegradely into the inferior vena cava to establish a pathway. Operators may use any device capable of rapid endovascular thrombus removal such as the AngioJet catheter (Boston Scientific, USA) and the Indigo catheter (Penumbra Inc, USA). However, catheter-directed thrombolysis (CDT) alone and the ClotTriever (Inari Medical, USA) is not permitted. After thrombus removal, the outcome is evaluated by venography. If iliac vein stenosis greater than 50% is detected, balloon dilation is performed using a balloon matched to the normal vessel diameter. If residual stenosis remains greater than 50% after balloon dilation, stent implantation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment with PFV-TC group | Experimental | Endovascular treatment with PFV-TC group (experimental group) Receives: Procedure: Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC) |
| Endovascular treatment without PFV-TC group | Active comparator | Endovascular treatment without PFV-TC group (control group) Receives: Procedure: Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Thrombotic Syndrome (PTS)
Assessed by the Villalta score. The Villalta scale is the recommended tool for diagnosing and grading the severity of PTS. It is a composite score based on 11 items (5 patient-reported symptoms and 6 clinician-assessed signs), each rated from 0 (absent) to 3 (severe), yielding a total score ranging from 0 to 33. A score of 0-4 indicates no PTS, whereas a score of ≥5 or venous ulcer confirms the diagnosis of PTS. Specifically, scores of 5-9 indicate mild PTS, 10-14 indicate moderate PTS, and a score of ≥15 or venous ulcer indicates severe PTS. Higher scores reflect greater disease severity.
Measured: at 24 months
Secondary outcomes (6)
Incidence of moderate-to-severe PTS
Assessed by the Villalta score
Measured: at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Assessed by color Doppler ultrasound and defined as respiratory phasic flow with stenosis <50% and no pathological collateral veins.
Measured: at 12 months and 24 months
Incidence of PTS
Assessed by the Villalta score
Measured: at 6 and 12 months
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
Measured: at 24 months
Rate of re-intervention
Assessed by documentation of clinical reintervention
Measured: at 24 months
Quality of life score
Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL). The minimum value is 0 and the maximum value is 100. Higher score means a better outcome.
Measured: at 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start24 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Central Hospital, West China Hospital, Chengdu University of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Changhai Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622199
- Sponsor's protocol ID
- The PROTECT Study
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, the study protocol, and the statistical analysis plan will be available beginning 3 months and ending 5 years after article publication to researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis: a Multicenter Randomized Controlled Study (The PROTECT Study)
- ClinicalTrials.gov ID
- NCT07622199
- Acronym / sponsor ID
- The PROTECT Study
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep venous thrombosis, Endovascular treatment, Profunda femoral vein, Post-thrombotic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Wenzhou Central Hospital, West China Hospital, Chengdu University of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Changhai Hospital, First People's Hospital of Hangzhou
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jun 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.
Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.
Detailed description
Acute lower extremity deep vein thrombosis (DVT) can lead to obstruction of veins, causing sudden lower limb swelling. Patients may also develop post-thrombotic syndrome (PTS) manifesting as recurrent lower limb swelling, skin disorders, and even non-healing ulcers, which severely affects the patient's quality of life. Among lower extremity DVT, thrombosis involving the iliofemoral veins is the most severe, with an incidence of PTS as high as 20%-50%. According to the results of a prospective clinical study, rapid endovascular thrombus removal can effectively improve the primary thrombus clearance rate and shorten hospital stay in patients with DVT. Among 329 patients, 192 (58.5%) achieved complete thrombus removal using the AngioJet catheter. This therapy was once considered to be the first-line treatment option for DVT. However, the results of the ATTRACT study, published in 2017 in New England Journal of Medicine found that there was no significant difference in the incidence of PTS at two years after pharmacomechanical catheter directed thrombolysis (PCDT) compared with anticoagulation alone. Although PCDT can rapidly remove thrombus, is it unable to improve the long-term outcomes for patients with DVT? According to previous studies, the primary patency rate at 12 months after PCDT for acute iliofemoral venous thrombosis ranges from 77% to 85%, while the incidence of PTS at 24 months postoperatively is as high as 40%. Residual thrombus is an important cause of thrombus recurrence, re-occlusion of the vein, and poor clinical outcomes. Previous studies have primarily focused on thrombus clearance in the popliteal vein, superficial femoral vein, common femoral vein, and iliac vein, while neglecting the assessment and clearance of profunda femoris vein (PFV) thrombosis. As the PFV is an important inflow of the iliofemoral vein, whether PFV-TC can improve the patency rate and clinical outcomes of endovascular treatment for acute iliofemoral DVT remains unclear. In a preliminary study, the investigators analyzed and compared two cohorts: one receiving conventional endovascular treatment for acute iliofemoral venous thrombosis, and the other receiving conventional treatment combined with profunda femoris vein thrombosis clearance (PFV-TC). The results showed that the 24-month patency rate of the iliofemoral vein was 90% vs. 72%, and the incidence of PTS was 11% vs. 32% (P=0.020). These findings were published in November 2025 in European Journal of Vascular and Endovascular Surgery. This study has garnered widespread attention, and de Wolf MAF published an invited commentary on this study, acknowledging the value of this approach in the endovascular treatment of acute iliofemoral DVT. Therefore, the investigators hypothesize that PFV-TC can improve inflow and reduce the incidence of PTS for iliofemoral DVT. However, high-level evidence is still lacking. The PROTECT study is a prospective, multicentre, randomised, open-label, outcome assessor-blinded, 1:1 parallel-group controlled clinical trial evaluating the efficacy and safety of PFV-TC in patients with acute iliofemoral DVT and PFV involvement, which aims to determine whether PFV-TC can reduce the incidence of PTS and provide clinical decision-making in this specific population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment with PFV-TC group | Experimental | Procedure: Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC)Endovascular treatment with PFV-TC group (experimental group) |
| Endovascular treatment without PFV-TC group | Active comparator | Procedure: Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)Endovascular treatment without PFV-TC group (control group) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 85 years;
- Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography);
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patient receives endovascular treatment with rapid endovascular thrombus removal device;
- Patient provides written informed consent.
Key exclusion criteria (13 listed)
- Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;
- Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
- Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;
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 |
|---|---|---|
| Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC)Endovascular treatment with PFV-TC group (experimental group): Based on the control group, access is obtained via the contralateral common femoral vein using a crossover technique, or via a popliteal-profunda communicating vessel approach to PFV. The thrombus status of the PFV is assessed, and rapid thrombus removal is performed on the PFV thrombosis. | Procedure or surgery | Endovascular treatment with PFV-TC group |
| Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)An appropriate puncture approach is selected, including the ipsilateral calf vein, ipsilateral popliteal vein, or ipsilateral femoral vein. Under ultrasound guidance, a vascular sheath is inserted after puncture, and systemic heparinization is performed. Using a guidewire and catheter, the guidewire is advanced antegradely into the inferior vena cava to establish a pathway. Operators may use any device capable of rapid endovascular thrombus removal such as the AngioJet catheter (Boston Scientific, USA) and the Indigo catheter (Penumbra Inc, USA). However, catheter-directed thrombolysis (CDT) alone and the ClotTriever (Inari Medical, USA) is not permitted. After thrombus removal, the outcome is evaluated by venography. If iliac vein stenosis greater than 50% is detected, balloon dilation is performed using a balloon matched to the normal vessel diameter. If residual stenosis remains greater than 50% after balloon dilation, stent implantation is performed. | Procedure or surgery | Endovascular treatment without PFV-TC group |
Primary outcome
Incidence of Post-Thrombotic Syndrome (PTS)
Time frame: at 24 months
Assessed by the Villalta score. The Villalta scale is the recommended tool for diagnosing and grading the severity of PTS. It is a composite score based on 11 items (5 patient-reported symptoms and 6 clinician-assessed signs), each rated from 0 (absent) to 3 (severe), yielding a total score ranging from 0 to 33. A score of 0-4 indicates no PTS, whereas a score of ≥5 or venous ulcer confirms the diagnosis of PTS. Specifically, scores of 5-9 indicate mild PTS, 10-14 indicate moderate PTS, and a score of ≥15 or venous ulcer indicates severe PTS. Higher scores reflect greater disease severity.
6 secondary outcomes
Incidence of moderate-to-severe PTS
Time frame: at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Time frame: at 12 months and 24 months
Incidence of PTS
Time frame: at 6 and 12 months
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Time frame: at 24 months
Rate of re-intervention
Time frame: at 24 months
Quality of life score
Time frame: at 6, 12, and 24 months
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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, the study protocol, and the statistical analysis plan will be available beginning 3 months and ending 5 years after article publication to researchers who provide a methodologically sound proposal.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC) and Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) in people with Deep Vein Thrombosis, run by RenJi Hospital at 1 site 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Qihong Ni (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Thrombotic Syndrome (PTS) (time frame: at 24 months). 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 13 Oct 2026.