Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

NCT05286710 | Recruiting DMC

• 1 other identifier: The Reformation Study
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).

Conditions

Deep Vein Thrombosis

Keywords

pharmacomechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of post-thrombotic syndrome (PTS)

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

  24 months

Secondary Outcomes (10)

• Immediate patency rate

  immediately after lonely mechanical thrombectomy

• Total time of interventional surgery

  immediately after interventional surgery

• Total dosage of urokinase

  immediately after interventional surgery

• Patency rate of lower limb vein

  post-interventional 12 and 24 months

• Deep venous valve function evaluation

  post-interventional 12 and 24 months

Other Outcomes (3)

• Safety outcomes - procedural complications

  Within 30 days after intervention

• Safety outcomes - major bleeding events

  Within 24 months after intervention

• all-cause death

  Within 24 months after intervention

Study Arms (2)

modified access group

EXPERIMENTAL

modified access: PMT was performed via distal calf venous access or contralateral femoral access

Device: pharmacomechanical thrombectomy (PMT)

traditional access group

ACTIVE COMPARATOR

traditional access: PMT was performed via ipsilateral popliteal venous access

Device: pharmacomechanical thrombectomy (PMT)

Interventions

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.

modified access group; traditional access group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• First People's Hospital of Hangzhou: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Liuzhou Workers' Hospital: collaborator
• Shanghai Pudong New Area People's Hospital: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40461147 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meng Ye, M.D.

  Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Ni Qihong, M.D.

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 18, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)