| CTRI Number |
CTRI/2024/04/066001 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Other (Specify) [Interventional Radiology] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Interventional Methods for Clearing Blood Clots in the Legs
|
|
Scientific Title of Study
|
Technical success and outcomes using novel Banode-Mishra Technique (BMT) versus endovascular Rotational Thrombectomy device in acute iliofemoral vein thrombolysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vadlamudi Nagendra |
| Designation |
Fellow in Interventional Radiology, MD Radio-diagnosis |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
Department of Interventional Radiology, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
MAHARASHTRA
442001
India |
| Phone |
8867799941 |
| Fax |
|
| Email |
nagvad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Banode |
| Designation |
HOD, Professor Radiology |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
Department of Interventional Radiology, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713020 |
| Fax |
|
| Email |
drpjbanode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pankaj Banode |
| Designation |
HOD, Professor Radiology |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
Department of Interventional Radiology, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713020 |
| Fax |
|
| Email |
drpjbanode@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus, Wardha, Maharashtra, India. 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Shalinitai Meghe Super-specialty Hospital, AVBRH Campus, Wardha, Maharashtra, India. 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vadlamudi Nagendra |
Datta Meghe Institute of Higher Education and Research |
1st Floor, Department of Interventional Radiology, Shalinitai Super specialty hospital, AVBRH Campus
Wardha
MAHARASHTRA |
8867799941
nagvad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I824||Acute embolism and thrombosis of deep veins of lower extremity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Banode-Mishra Technique (BMT). |
The novel technique for thrombus recanalization incorporates the use of a suitable pigtail catheter which will be positioned at the thrombus site in a small area created by thrombus maceration by suitable hydrophilic guidewire. This will be followed by forceful intravenous injection of 1 to 2 ml of Actilyse (Alteplase 10mg in 50ml solution of normal saline). The vial of the said drug comes in 20mg, 50mg and 100mg respectively. The 20mg vial will be made use of. The pigtail catheter will then be rotated by 90 degree and withdrawn post rotation by about 1 to 2 cm distally. Then, another forceful injection of 2 cm Actilyse is administered and the catheter is withdrawn about 2 cm distally. This process will be cyclically carried out in repetition until the entire thrombotic segment has been covered. Then, after a time period of about 4 hours, mechanical thrombolysis will be carried out until the endpoint is achieved which will be subject to the post procedural venogram. The time duration or endpoint for the technique aims at maximum thrombus recanalization after mechanical catheter directed thrombolysis with reference to vessel patency. |
| Comparator Agent |
endovascular Rotational Thrombectomy device (Cleaner XT) |
cleaner xt device is used for thrombolysis. Frequency is once, route of administration is intravenous & total duration of such intervention depends on the thromubus load of patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary acute iliofemoral DVT |
|
| ExclusionCriteria |
| Details |
Patient unable to provide informed consent
Sepsis or active infection
Recent intracranial bleed or gastrointestinal bleed within the past three months
Allergy to iodinated contrast media, antiplatelet drugs, heparin
Pregnancy
Life expectancy less than 12 months based on physicians estimate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of BMT over cleaner XT device. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Deep venous thrombosis (DVT) is a major public health problem resulting in significant morbidity and mortality, having 0.1% per year incidence in the adult population. Standard treatment includes medical anticoagulant therapy or pharmacomechanical catheter-directed thrombolysis. Despite the use of anticoagulant therapy, ATTRACT trial demonstrated that post thrombotic syndrome develops over two years in approximately 50% of patients with lower extremity DVT. At our hospital, we have used Banode Mishra technique© as a novel approach in the treatment of iliofemoral vein thrombolysis and compared the findings with another group of patients who were treated with Cleaner 15TM rotational thrombectomy device. A randomized control interventional study will be conducted and carried out in patients with acute iliofemoral DVT requiring thrombolysis and admitted in department of interventional radiology, AVBRH, Datta Meghe Institute of Higher Education and Research. |