AzTrials
AzTrials

Deep Vein ThrombosisNCT05286710

Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

A study testing pharmacomechanical thrombectomy (PMT) in people with Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
pharmacomechanical thrombectomy (PMT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Sep 2022to 31 Dec 2027
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

  • Age between 18-80 years old;
  • Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
  • DVT with thrombosis involving the iliac vein, common femoral vein, distal popliteal vein, and/or calf vein;
  • Informed consent signed by patients.

Who cannot join

  • Patients with the previous history of the same side of lower-limb DVT;
  • Patients with plasma Creatinine level greater than 180umol/L;
  • Patients who are contraindicated to thrombolysis;
  • Patients with inferior vena cava thrombosis;
  • Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
  • Patients who have participated in a clinical trial in the past three months;
Show all 10Show fewer
  • Women during pregnancy and lactation
  • Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
  • Patients with autoimmune thrombopathy or thrombocytopenia (platelets < 80·10⁹/L);
  • Patients who are unable or unwilling to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ni Qihong, M.D. contact

+8615801900772

niqihong1989@163.com

China1 site, 1 recruiting

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

    Ni Qihong, M.D., +86 15801900772, niqihong1989@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance

Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).

Read the detailed description

Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.

Being tested
pharmacomechanical thrombectomy (PMT)
Keywords
pharmacomechanical thrombectomy
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pharmacomechanical thrombectomy (PMT)Device

    After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein. After PMT treatment, residual thrombus was reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus. Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was >50% after PTA treatment.

Study groups in NCT05286710
Study groupRoleWhat they receive
modified access groupExperimentalmodified access: PMT was performed via distal calf venous access or contralateral femoral access
Receives: Device: pharmacomechanical thrombectomy (PMT)
traditional access groupActive comparatortraditional access: PMT was performed via ipsilateral popliteal venous access
Receives: Device: pharmacomechanical thrombectomy (PMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post-thrombotic syndrome (PTS)

    Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months

    Measured: 24 months

Secondary outcomes (10)

  1. Immediate patency rate

    Percentage of patency rate immediately after lonely mechanical thrombectomy

    Measured: immediately after lonely mechanical thrombectomy

  2. Total time of interventional surgery

    Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)

    Measured: immediately after interventional surgery

  3. Total dosage of urokinase

    Total dosage measured by units of urokinase used for procedure

    Measured: immediately after interventional surgery

  4. Patency rate of lower limb vein

    Percentage of patency rate of lower limb vein at post-interventional 12 and 24 months

    Measured: post-interventional 12 and 24 months

  5. Deep venous valve function evaluation

    Deep venous valve function evaluation by ultrasound at post-interventional 12 and 24 months

    Measured: post-interventional 12 and 24 months

  6. Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)

    Quality of life evaluated by 36-Item Short Form Health Survey (SF-36). The change in SF-36 Physical and Mental Component Scales from baseline to 24 months will be compared between the two groups using a t-test. A difference of 5 points on each scale is considered to be clinically relevant. In addition, a linear mixed model analysis of the repeated assessments (3, 6, 12, and 24 months) with baseline scores as a covariate will be used to investigate the changes over time, and if they differ by treatment arm.

    Measured: post-interventional 3, 6, 12 and 24 months

  7. Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score

    Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118. The higher scores mean a better outcome.

    Measured: post-interventional 3, 6, 12 and 24 months

  8. European quality of life 5-dimension 5-level (EQ-5D-5L) score

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: post-interventional 3, 6, 12 and 24 months

  9. Re-intervention rate

    Percentage of re-intervention rate within 24 months after operation

    Measured: within 24 months after operation

  10. Rate of catheter-directed thrombolysis

    Percentage of catheter-directed thrombolysis after mechanical thrombectomy

    Measured: immediately after interventional surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286710
Sponsor's protocol ID
The Reformation Study
Status last verified
May 2025
First submitted
6 Mar 2022
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ni Q, Ye X, He C, Zhao H, Lou W, Zhuang H, Sang H, Wu Z, Ye M. Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study). BMJ Open. 2025 Jun 3;15(6):e089797. doi: 10.1136/bmjopen-2024-089797.

    PubMed 40461147

Questions about this trial

What is this clinical trial studying?

A study testing pharmacomechanical thrombectomy (PMT) 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 4 inclusion and 10 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 15 May 2025. 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 Ni Qihong, M.D. (+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: 24 months). 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 NCT05286710, which also lists 1 linked publication.

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 15 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in