| CTRI Number |
CTRI/2025/07/089933 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Safety and Performance of Balloon Catheter in Below the knee arteries |
|
Scientific Title of Study
|
A Post Market Clinical Study to Evaluate the Clinical Safety and Performance of Peripherics Paclitaxel-coated Balloon Catheter in the Treatment of Below-the-Knee Arteries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P-BTK(P)-001 Ver 1.0 Dt 03 Dec 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varinder Singh Bedi |
| Designation |
Senior Consultant Vascular & Endovascular surgery |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Vascular Surgery
SGRH Marg. Rajinder Nagar
New Delhi India
New Delhi
DELHI
110060
India |
| Phone |
9560194990 |
| Fax |
|
| Email |
bedivs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varinder Singh Bedi |
| Designation |
Senior Consultant Vascular & Endovascular surgery |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
SGRH Marg. Rajinder Nagar
New Delhi India
DELHI
110060
India |
| Phone |
9560194990 |
| Fax |
|
| Email |
bedivs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varinder Singh Bedi |
| Designation |
Senior Consultant Vascular & Endovascular surgery |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
SGRH Marg. Rajinder Nagar
New Delhi India
DELHI
110060
India |
| Phone |
9560194990 |
| Fax |
|
| Email |
bedivs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Estate, Wakhariawadi, Near Dabholi Char Rasta, Ved
Road, Surat-395004, India |
|
|
Primary Sponsor
|
| Name |
Sahajanand Medical Technologies Limited |
| Address |
Sahajanand Estate, Wakhariawadi, Near Dabholi Char Rasta, Ved
Road, Surat-395004, India |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit PV Nair |
Aster Medcity |
Department of Vascular
South Chittoor, Cheranelloor,
Kochi 682027
Ernakulam
KERALA |
9846056022
drrohit.nair@asterhospital.com |
| Dr P C Gupta |
CARE Hospitals |
Department of Vascular & Endovascular Surgery CARE Hospitals Outpatient Centre, Banjara Hills, Hyderabad 500034 India
Hyderabad
TELANGANA |
9848053220
vasculartherapy@gmail.com |
| Dr Narendranadh Meda |
Krishna Institute of Medical Sciences |
Department of Vascular,
Minister Road, Secunderabad-500003
Hyderabad
TELANGANA |
9704084841
narenmeda@gmail.com |
| Dr Anurag Polavarapu |
Lalitha Super Specialities Hospital |
Department of Cardiovascular Surgery
Kothapet Guntur
Guntur
ANDHRA PRADESH |
9866391141
anurag.polavarapu@gmail.com |
| Dr Prashant Sarda |
Shri Mahant Indiresh Hospital |
OPD Department, Patel Nagar, Dehradun, 248001, Uttarakhand, India
Dehradun
UTTARANCHAL |
8335912713
drprashantsarda1@gmail.com |
| Dr Varinder Singh Bedi |
Sir Ganga Ram Hospital |
SGRH Marg, Rajinder Nagar,
New delhi-110060
New Delhi
DELHI |
9560194990
bedivs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Aster Medicity |
Approved |
| Institutional Ethics Committee SGRRIMHS |
Submittted/Under Review |
| Institutional Ethics Committee, CARE Hospitals |
Submittted/Under Review |
| KIMS Ethics Committee |
Submittted/Under Review |
| Lalitha Super Specialities Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Nil |
Nil |
| Intervention |
Peripherics paclitaxel-coated
PTA balloon catheter |
Peripherics Paclitaxel-coated
PTA Balloon Catheter are over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter with a drug coated balloon fixed at the distal tip 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Rutherford Clinical Category 3-5
Significant stenosis or occlusion of one or two native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment
Patient is willing to provide informed consent, and is willing to comply with the protocol required follow-up visits and recommended medication regimen |
|
| ExclusionCriteria |
| Details |
Life expectancy of less than 1-year
Lesions and/or occlusions located or extending into the popliteal artery or below the ankle joint space.
Inflow lesion or occlusion in the ipsilateral Iliac, superficial femoral artery (SFA), popliteal arteries with a length equal to or above 15 cm.
Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
Known allergy to concomitant medication, paclitaxel, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications.
Patient with any medical condition that would make him/her inappropriate for treatment with Peripherics paclitaxel-coated balloon catheter as per the current IFU or in the opinion of the Investigator
Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure
Patients with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation
Evidence of aneurysm or acute thrombus in the target vessel(s)
Previously implanted stent in target lesion(s)
Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure
Presence of concentric calcification that precludes adequate vessel preparation as per the current IFU
Patients confined to bed that are completely non-ambulatory |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major Adverse Limb Events (MALE) with perioperative all-cause death |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Major Adverse Events (MAE) |
12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/07/2025 |
| 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="2"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
|
Peripheral Arterial Disease (PAD) occurs when a narrowing, or blockage, develops in the arteries; PAD most commonly affects the legs. Endovascular options are frequently performed as the first line of therapy in patients with chronic limb-threatening ischemia. The endovascular treatment landscape encompasses a broad range of interventions, and each option has unique advantages and disadvantages. Drug-coated balloons (DCBs) were developed to address some of these concerns, and numerous randomized controlled trials (RCTs) have demonstrated that DCBs are safe and more effective for the treatment of patients with below the knee arteries during routine clinical practice. The treatment strategy will be determined by the Investigator. It is recommended that each enrolling investigator review Peripherics paclitaxel-coated balloon catheter Instructions for Use and assess the contraindications, warnings, and precaution sections with respect to risks and benefits for treating potential patients. |