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CTRI Number  CTRI/2024/12/078769 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between the long term outcome of lower limb peripheral vascular disease recanalization by atherectomy with drug coated balloon versus atherectomy with stenting 
Scientific Title of Study   Comparison of the efficacy, safety & patency of combined Directional Atherectomy with Drug-Coated Balloon Angioplasty versus combined Directional Atherectomy with Vascular mimetic Stent placement for the treatment of femoropopliteal atherosclerotic Peripheral Vascular Disease- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyam Barchha 
Designation  MBBS, MD 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE, KLES UNIVERSITY 
Address  Dept of Interventional Radiology, KLES Dr Prabhakar Kore Hospital and MRC, Nehrunagar, Belagavi
Jawaharlal Nehru Medical College, Nehrunagar, Belagavi 590019
Belgaum
KARNATAKA
590019
India 
Phone  9409208193  
Fax    
Email  satyam.ircases@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Navin Mulimani 
Designation  MBBS, MD, DM 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE, KLES UNIVERSITY 
Address  Dept of Interventional Radiology, KLES Dr Prabhakar Kore Hospital And MRC, Nehrunagar, Belagavi
JAWAHARLAL NEHRU MEDICAL COLLEGE, NEHRUNAGAR, BELAGAVI 590019
Belgaum
KARNATAKA
590019
India 
Phone  9409208193  
Fax    
Email  navinmulimani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Satyam Barchha 
Designation  MBBS, MD 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE, KLES UNIVERSITY 
Address  Dept of Interventional Radiology, KLES Dr Prabhakar Kore Hospital and MRC, NEhrunagar , Belagavi
Jawaharlal Nehru Medical College, Nehrunagar, Belagavi -590019
Belgaum
KARNATAKA
590019
India 
Phone  9409208193  
Fax    
Email  satyam.ircases@gmail.com  
 
Source of Monetary or Material Support  
Department of Interventional Radiology, KLES Dr Prabhakar Kore Hospital and MRC 
 
Primary Sponsor  
Name  Department of Interventional Radiology KLES Prabhakar Kore Hospital and MRC 
Address  KLES Dr. Prabhakar Kore Hospital and MRC, Nehrunagar, BELAGAVI 590019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Satyam Barchha  KLES Prabhakar Kore Hospital and MRC  KLES Prabhakar Kore Hospital and MRC, Nehrunagar, BELAGAVI
Belgaum
KARNATAKA 		 9409208193

satyam.ircases@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DIRECTIONAL ATHERECTOMY WITH DRUG COATED BALLOON ANGIOPLASTY  Endovascular Directional Atherectomy of the lesion will be performed with a 6F Directional Atherectomy System followed by Drug coated Balloon Angioplasty of the lesion. Medical devices (Directional Atherectomy system, Vasculomimetic stent and Drug coated balloon) are being used in both the arms of the study. The route is endovascular by transarterial access and the intervention will be performed only once in the patient. The Drug coated balloon used in the study is Paclitaxel coated and the dose is 3.25 micrograms per square millimetre of the surface of the balloon which will be released into the arterial wall to cause a local effect  
Comparator Agent  DIRECTIONAL THERECTOMY WITH VASCULOMIMETIC STENT PLACEMENT  Endovascular Directional Atherectomy of the lesion will be performed with a 6F Directional Atherectomy System followed by vascular mimetic stent placement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Patients with symptomatic chronic lower limb ischemia (Rutherford category 2 to 6) with lifestyle-limiting symptoms such as claudication pain, ischemic rest pain, ischemic ulceration, or gangrene.
Imaging (CT / MR angiography) evidence of ≥70% stenosis, or occlusion of the superficial femoral (SFA) or popliteal artery (PA).
Preserved distal perfusion of foot via at least one below knee vessel or collaterals
 
 
ExclusionCriteria 
Details  Clinical or imaging (Duplex ultrasound/CT/MR/DSA angiography) evidence of acute limb ischemia.
Previous history of endovascular intervention or bypass surgery of the target limb.
Contraindication to antiplatelet therapy, anticoagulants, or any other medication that is planned to be administered.
Known hypersensitivity to treatment device material or iodinated contrast agents, that cannot be sufficiently pre-treated.
End-stage renal disease.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Technical success, Net luminal gain, Primary patency rate  One day, Six months, One year 
 
Secondary Outcome  
Outcome  TimePoints 
Complication rate  One day, Six months, One year 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/01/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [satyam.ircases@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Through this single centre prospective randomized parallel group open label study, we aim to compare the efficacy, safety and patency rates of combined directional atherectomy with drug-coated balloon angioplasty (DCB) versus combined directional atherectomy with vascular mimetic stent placement for treatment of lower limb peripheral arterial disease involving the superficial femoral and popliteal arteries.

 
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