| CTRI Number |
CTRI/2024/03/063744 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Safety and Performance of Balloon Catheter in Superficial Femoral and Popliteal Arteries |
|
Scientific Title of Study
|
A Prospective, Multicenter, Single Arm, Post-Market Study to Assess the Clinical Safety and Performance of Peripherics
Paclitaxel-coated PTA Balloon Catheter in Superficial Femoral and Popliteal Arteries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P-SFA/PA(P)-001 Version 1.0 dated May 05, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P C Gupta |
| Designation |
Clinical Director and HOD, Vascular and Endovascular surgery & Vascular IR |
| Affiliation |
CARE Hospitals |
| Address |
Department of Vascular & Endovascular Surgery
CARE Hospitals Outpatient Centre, Banjara Hills,
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P C Gupta |
| Designation |
Clinical Director and HOD, Vascular and Endovascular surgery & Vascular IR |
| Affiliation |
CARE Hospitals |
| Address |
Department of Vascular & Endovascular Surgery
CARE Hospitals Outpatient Centre, Banjara Hills,
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P C Gupta |
| Designation |
Clinical Director and HOD, Vascular and Endovascular surgery & Vascular IR |
| Affiliation |
CARE Hospitals |
| Address |
Department of Vascular & Endovascular Surgery
CARE Hospitals Outpatient Centre, Banjara Hills,
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
vasculartherapy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Medical Technologies Limited
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 Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKrishna Chaitanya KH |
Aster CMI Hospital |
Ground Floor, Old OPD # 43/2, New Airport Road NH 7, Outer Ring Rd, Sahakar Nagar, Hebbala, Bengaluru, Karnataka 560092 India
Bangalore Rural
KARNATAKA |
9573733117
krishna.kh@asterhospital.com |
| Dr Rohit Nair |
AsterMed City Hospital |
Department of Vascular
Aster Medcity, South Chittoor, Cheranelloor, Kochi, Kerala-682027
Ernakulam
KERALA |
9846056022
drrohit.nair@asterhospital.in |
| Dr P C Gupta |
CARE Hospitals |
Department of Vascular & Endovascular Surgery,
CARE Hospitals,
CARE Hospitals Outpatient Centre, Banjara Hills,
Hyderabad- 500034, Telangana, India
Hyderabad
TELANGANA |
9848053220
vasculartherapy@gmail.com |
| Dr Narendranadh Meda |
Krishna Institute of Medical Sciences |
Department of Vascular,
Minister Road, Secunderabad-500003, Telangana
Hyderabad
TELANGANA |
9704084841
narenmeda@gmail.com |
| Dr Anurag Polavarapu |
Lalitha Super Specialities Hospital |
Department of Cardiology & Vascular
Kothapet, Guntur 522 001
Guntur
ANDHRA PRADESH |
8632222866
anurag.polavarapu@gmail.com |
| Dr Virender Sheorain |
Medanta The Medicity Hospitals |
Department of Vascular,
CH Baktawar Singh Road, Medicity, Islampur
Colony, Sector 38, Gurugram, Haryana, 122001
Gurgaon
HARYANA |
9868887666
veeru40395@gmail.com |
| Dr Prashant Sarda |
Shri Mahant Indiresh Hospital |
OPD Department, Patel Nagar, Dehradun, 248001, Uttarakhand, India
Dehradun
UTTARANCHAL |
8335912713
drprashhantsarda1@gmail.com |
| Dr Varinder Singh Bedi |
Sir Ganga Ram Hospital |
Dept of Vascular
SGRH Marg, Rajinder Nagar, New delhi-110060
New Delhi
DELHI |
9560194990
bedivs@gmail.com |
| Dr Ram Bhavin Laxmanbhai |
Yashoda Hospitals |
Dept of Vascular
Behind Hari Hara Kala Bhavan, SP Road, Secunderabad 500003
Hyderabad
TELANGANA |
953809022
drbhavinram@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Submittted/Under Review |
| IEC_Aster CMI Hospital |
Approved |
| Institutional Ethics Committee SGRRIMHS |
Approved |
| Institutional Ethics Committee, CARE Hospitals |
Approved |
| Institutional Ethics Committee_YAMER |
Approved |
| KIMS Ethics Committee |
Approved |
| Lalitha Super Specialities Hospital Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
| Ripon Independent 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 |
NA |
| 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 |
1. Age ≥ 18 years
2. Patient with documented diagnosis of peripheral arterial disease in SFA and/or PA classified as Rutherford class 3-5
3. Lesion(s) in SFA and/or PA suitable for endovascular treatment, scheduled to be treated with Peripherics paclitaxel-coated PTA balloon catheter according to Instructions For Use (IFU)
Allowed lesion location: Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the Tibioperoneal (TP) trunk.
4. Target lesion(s) must either be de-novo or non-stented re-stenotic lesion(s). If the target lesion(s) is re-stenotic, the prior PTA must have been done more than 30 days prior-index procedure
5. Target lesion(s) can be treated with available Peripherics paclitaxel-coated PTA balloon catheter’s size matrix per the current IFU
6. Patient provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site
7. Patient agrees to comply with the protocol-mandated follow-up procedures and visits
8. At least one native artery with direct outflow artery to the foot |
|
| ExclusionCriteria |
| Details |
1. Life expectancy of less than 1 year
2. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet
3. Patient is pregnant or planning to become pregnant during the course of the study
4. Known allergy to concomitant medication, paclitaxel, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications
5. Patient with any medical condition that would make him/her inappropriate for treatment with Peripherics paclitaxel-coated PTA balloon catheter as per the current IFU or in the opinion of the Investigator
6. Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
7. Evidence of aneurysm or acute thrombus in the target vessel(s)
8. Previously implanted stent in target lesion(s)
9. Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Freedom from Major Adverse Events (MAE)
Freedom from MAE defined as, a composite of freedom from all-cause mortality, freedom from major target limb amputation, and freedom from clinically
driven target lesion revascularization (CD-TLR) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Freedom from Major Adverse Events
2. Primary patency. Primary patency defined as freedom from CD-TLR and freedom from
restenosis as determined by duplex ultrasound
3. All-cause mortality
4. Major target limb amputation
5. CD-TLR
6. Change in mean Ankle Brachial Index (ABI) compared to the pre-procedure
7. Improvement in Rutherford classification compared to the pre-procedure
8. Amputation-free survival (AFS) including major, minor, and overall AFS
9. Walking Impairment Questionnaire (WIQ)
10. Device success
11. Technical success
12. Procedural Success
13. Quality of Life Assessment by VascuQoL-6 |
3 months, 6 months and 12 months
6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
30 days, 3 months, 6 months and 12 months
Immediate Upon Procedure
Immediate Upon Procedure
Immediate Upon Procedure
30 days, 3 months, 6 months and 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)
|
15/04/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - 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 SFA/PA than uncoated balloon angioplasty. This study is to assess the clinical safety and performance of Peripherics paclitaxel coated PTA balloon catheter in superficial femoral artery and/or popliteal artery during routine clinical practice. |