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CTRI Number  CTRI/2020/05/025285 [Registered on: 21/05/2020] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   AMBULATE EARLY TRAIL 
Scientific Title of Study   A Prospective Trail Comparing Safety and Efficacy of Collagen based vs Suture based Vascular Closure Device and Manual Compression in Patients who have Undergone Femoral Artery Puncture Interventional Procedure 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology  
Affiliation  All India Institute. of Medical Science , Rishikesh  
Address  Room No. 025103 Fifth Floor , Deparment of Cardiology All India Institute of Medical Science Rishikesh Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology  
Affiliation  All India Institute. of Medical Science , Rishikesh  
Address  Room No. 025103 Fifth Floor , Deparment of Cardiology All India Institute of Medical Science Rishikesh Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology  
Affiliation  All India Institute. of Medical Science , Rishikesh  
Address  Room No. 025103 Fifth Floor , Deparment of Cardiology All India Institute of Medical Science Rishikesh Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Source of Monetary or Material Support  
Meril Life Science Private Limited  
 
Primary Sponsor  
Name  Rohit Walia  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Dehradun , Uttarakhand  
Type of Sponsor  Other [Principal Investigator ] 
 
Details of Secondary Sponsor  
Name  Address 
Meril Life Science Private Limited   Bilakhia House , Survey no. 135/139, Vapi , Valsad , Gujrat , India.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Walia   All India Institute of Medical Science , Rishikesh   Room no. 25103, Department of Cardiology , All India Institute of Medical Science Virbhadra Road , Pashulok , Rishikesh ,
Dehradun
UTTARANCHAL 		 8800492549

rwalia7731@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science , Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I209||Angina pectoris, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vascular closure device - collagen based vs suture based   Vascular closure device are used to seal the puncture site after femoral artery puncture based interventions and this allows early ambulation and rapid hemostasis 
Comparator Agent  Vascular closure device : collagen based vs. suture based vs. femoral compression  Vascular closure device are either suture based or collagen based to seal the vessel puncture site after intervention. We will compare suture based vs. collagen based vs. femoral compression. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age greater than 18 years , valid informed consent , posted for femoral artery puncture based diagnostic or interventional procedure 
 
ExclusionCriteria 
Details  vascular graft or a re-puncture at a site previously punctured within 48 hours or planned arterial access at the same access site within 30 days of catheterisation bleeding disorder , significant anemia
allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers.
Patients undergoing thrombolytic therapy or treated with Warfarin within 24 hours prior to catheterization.
Patients who are known or suspected to be pregnant or is lactating.
Patients with uncontrolled hypertension with systolic blood pressure greater than 180 mmHg, unless systolic pressure can be lowered by pharmacological agents prior to closure.
Peripheral vascular disease  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to Haemostasis   Time to Haemostasis  
 
Secondary Outcome  
Outcome  TimePoints 
Time to ambulation, patient satisfaction, and vascular complications are secondary endpoints.  Day 2  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The project compares various vascular closure devices available for safety and efficacy in femoral artery puncture intervention procedures. Collagen based vascular closure devices and suture based will be used and compared in terms of time to hemostasis , time to ambulation and safety profile and various complications. ultrasound evaluation of he puncture site will also be done at baseline , post deployment and at six months.


 
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