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CTRI Number  CTRI/2019/05/018886 [Registered on: 01/05/2019] Trial Registered Prospectively
Last Modified On: 30/04/2019
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [Medical Device]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Paximusâ„¢ Randomized Controlled Trial 
Scientific Title of Study   A prospective, multicenter, open label, randomized controlled trial to evaluate safety and performance of Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter) versus Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries. 
Trial Acronym  Paximusâ„¢ RCT - 1 
Secondary IDs if Any  
Secondary ID  Identifier 
MLS/Paximusâ„¢ RCT - 1 Version 2.0.0 dated 08th October 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Thakkar 
Designation  Head of the Department - Clinical Research and Medical Writing 
Affiliation  Meril Life Sciences Pvt. Ltd. 
Address  Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi

Valsad
GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Thakkar 
Designation  Head of the Department - Clinical Research and Medical Writing 
Affiliation  Meril Life Sciences Pvt. Ltd. 
Address  Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi


GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Thakkar 
Designation  Head of the Department - Clinical Research and Medical Writing 
Affiliation  Meril Life Sciences Pvt. Ltd. 
Address  Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi


GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Source of Monetary or Material Support  
Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India. 
 
Primary Sponsor  
Name  Meril Life Sciences Pvt Ltd  
Address  Meril Life Sciences Pvt. Ltd. Bilakhia House, Survey No. 135139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India. 
Type of Sponsor  Other [Medical Device Company] 
 
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 Adarsh Kabra  Apex Hospitals Pvt. Ltd  Room No. 18, Department of Vascular Endosurgery and Interventional Radiology, SP 4-6, Malviya Nagar Industrial Area, Jaipur-302017 , Rajasthan, India
Jaipur
RAJASTHAN 		 8290912888

aadarsh61@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Apex Hospitals Pvt. Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mozecâ„¢ PTA Balloon Catheter  Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries. 
Intervention  Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter)  Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter)for treatment of blocked or narrowed below the knee arteries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Male or non-pregnant female ≥18 to ≤80 years of age.
2. Patient or his/her legally acceptable representative (LAR) willing to provide informed consent and comply with the required study procedures and visits.
3. Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure.
4. Female patient of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure. For a female patient of childbearing potential a pregnancy test must be performed with negative results at screening visit.
5. Female patient not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 2 years from the date of index procedure.
6. Clinically all patients must be in Rutherford category 2 to 5.
7. One identifiable single solitary or a series of multiple adjacent lesions in the blocked or narrowed arteries below the knee due toPeripheral Artery Disease (PAD) defined as ≥70% diameter stenosis with length in the range of ≥20 mm to ≤150 mm.
8. If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
9. Patients planned for PK analysis must agree to undergo PK follow-ups as per protocol. 
 
ExclusionCriteria 
Details  1. Patient with known hypersensitivity to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
2. Patient with known allergies or sensitivity to paclitaxel.
3. Patient having gastrointestinal bleeding or coagulopathy.
4. Patient having target lesion that the investigator is unable to cross by a guide wire.
5. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper of the delivery system.
6. Patient is probable case of stenting for the target lesion during the screening as per adjudication of investigator.
7. Patient with severe renal insufficiency (serum creatinine >2.0 mg/dL).
8. Untreated ipsilateral iliac artery.
9. Acute aneurysm in target the target vessel.
10. Patient participating in another device or drug study at the time of consenting process.
11. Major surgical procedures (viz. major invasive procedures or endovascular interventions for peripheral artery disease etc. or surgeries that might impact safety of participating patients as per discretion of investigator) within 30 days prior to this study or planned within 2 years after entry into this study.
12. Patient with life expectancy less than 2 years.
13. Adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon etc) within 30 days prior to this study or planned within 30 days of entry into this study.
14. Patient who required bailout stenting.
15. Diagnosed with cancer or malignancy
16. Any medical condition, which in investigator’s opinion, may interfere with patient’s participation in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Major adverse event [Time Frame: 6 months]
- Major adverse event is defined as all-cause death, target limb amputation and clinically driven target lesion revascularization (CD-TLR) 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Primary Patency  At post-procedure and after 6 months  
Late Lumen Loss  At post-procedure and after 6 months  
All cause of death  At Post-procedure, 1 month, 6 months , 12 months and 24 months 
Clinically driven TLR (CD-TLR)  At Post-procedure, 1 month, 6 months , 12 months and 24 months 
Target limb amputation  At Post-procedure, 1 month, 6 months , 12 months and 24 months 
Change of Ankle-Brachial index (ABI)  At Baseline, Post-procedure, 1 month, 6 months , 12 months and 24 months  
Walking Impairment Questionnaire (WIQ)   At 1 month, 6 months, 12 months and 24 months  
Change in Rutherford Classification   At Baseline, Post-procedure, 1 month, 6 months, 12 months and 24 months  
Device Success  During index procedure 
Procedural Success  At Post-procedure 
User Rating on Technical Properties   At index procedure  
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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)   15/07/2019 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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   This is a prospective, multicenter, open label, randomized controlled trial to evaluate safety and performance of Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter) versus Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries in approximately 280 patients 
The objective of the study is to compare safety and performance of Paximusâ„¢ with a Mozecâ„¢ PTA balloon for treatment of blocked or narrowed below the knee arteries and to evaluate in-human pharmacokinetics (PK) of the drug in Paximusâ„¢.  All patients will be approached to sign Informed Consent Form approved by respective Ethics Committee before starting the study related process.
 After screening for eligibility, patients found eligible for this study will be randomly assigned to either paclitaxel-based drug-eluting balloon (DEB) angioplasty or standard balloon angioplasty in 1:1 ratio using computer - generated randomization system.
30% of the patients will be considered for LLL analysis based on patients’ consent.
14 patients will be considered for PK analysis.
 
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