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Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Primary Purpose

Deep Vein Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pharmacomechanical thrombectomy (PMT)
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring pharmacomechanical thrombectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 iliac vein, femoral vein popliteal vein and calf vein;
  • Informed consent signed by patients.

Exclusion Criteria:

  • 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
  • Patients who are unable or unwilling to participate in the study.

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

modified access group

traditional access group

Arm Description

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

traditional access: PMT was performed via ipsilateral popliteal venous access

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immediate patency rate
Percentage of patency rate immediately after lonely mechanical thrombectomy
Total time of interventional surgery
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
Total dosage of urokinase
Total dosage measured by units of urokinase used for procedure
Patency rate of lower limb vein
Percentage of patency rate of lower limb vein at post-interventional 24 months
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.
Re-intervention rate
Percentage of re-intervention rate within 24 months after operation
Rate of catheter-directed thrombolysis
Percentage of catheter-directed thrombolysis after mechanical thrombectomy

Full Information

First Posted
March 6, 2022
Last Updated
May 10, 2023
Sponsor
RenJi Hospital
Collaborators
First People's Hospital of Hangzhou, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Nantong University, Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Suzhou University, Liuzhou Workers Hospital, Shanghai Pudong New Area People's Hospital, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05286710
Brief Title
Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
First People's Hospital of Hangzhou, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Nantong University, Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Suzhou University, Liuzhou Workers Hospital, Shanghai Pudong New Area People's Hospital, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
pharmacomechanical thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified access group
Arm Type
Experimental
Arm Description
modified access: PMT was performed via distal calf venous access or contralateral femoral access
Arm Title
traditional access group
Arm Type
Active Comparator
Arm Description
traditional access: PMT was performed via ipsilateral popliteal venous access
Intervention Type
Device
Intervention Name(s)
pharmacomechanical thrombectomy (PMT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of post-thrombotic syndrome (PTS)
Description
Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Immediate patency rate
Description
Percentage of patency rate immediately after lonely mechanical thrombectomy
Time Frame
immediately after lonely mechanical thrombectomy
Title
Total time of interventional surgery
Description
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
Time Frame
immediately after interventional surgery
Title
Total dosage of urokinase
Description
Total dosage measured by units of urokinase used for procedure
Time Frame
immediately after interventional surgery
Title
Patency rate of lower limb vein
Description
Percentage of patency rate of lower limb vein at post-interventional 24 months
Time Frame
post-interventional 24 months
Title
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score
Description
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.
Time Frame
post-interventional 24 months
Title
Re-intervention rate
Description
Percentage of re-intervention rate within 24 months after operation
Time Frame
within 24 months after operation
Title
Rate of catheter-directed thrombolysis
Description
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Time Frame
immediately after interventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 iliac vein, femoral vein popliteal vein and calf vein; Informed consent signed by patients. Exclusion Criteria: 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 Patients who are unable or unwilling to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ni Qihong, M.D.
Phone
+8615801900772
Email
niqihong1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Ye, M.D.
Organizational Affiliation
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ni Qihong, M.D.
Phone
+86 15801900772
Email
niqihong1989@163.com

12. IPD Sharing Statement

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Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

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