| CTRI Number |
CTRI/2023/07/055745 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Post-market study of safety and performance of the Peripherics paclitaxel-coated balloon catheter in superficial femoral and popliteal arteries. |
|
Scientific Title of Study
|
A retrospective, multicenter, single arm, post-market study to assess the clinical safety and performance of Peripherics paclitaxel-coated balloon catheter in superficial femoral and popliteal arteries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P-SFA/PA(R)-001, Version 1.0, 26 December 2022 |
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 Outpatient Centre, Road No.10, Banjara Hills, Hyderabad-500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
pcguptavascular@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 Outpatient Centre, Road No.10, Banjara Hills, Hyderabad-500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
pcguptavascular@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 Outpatient Centre, Road No.10, Banjara Hills, Hyderabad-500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9848053220 |
| Fax |
|
| Email |
pcguptavascular@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Medical Technologies Ltd. (SMT), Sahajanand Estate, Wakhariawadi, Near Dabholi, Ved Road, Surat – 395004, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr P C Gupta |
| Address |
CARE Hospitals, CARE Outpatient Centre, Road No.10, Banjara Hills, Hyderabad-500034, Telangana, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P C Gupta |
CARE Hospitals |
Department of vascular and endovascular surgery and vascular IR, CARE Outpatient Centre, Road No.10, Banjara Hills, Hyderabad-500034, Telangana, India
Hyderabad
TELANGANA |
9848053220
pcguptavascular@gmail.com |
| Dr Varinder Singh Bedi |
Sir Ganga Ram Hospital |
Department of Peripheral Vascular & Endovascular Surgery, Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI |
9968094990
bedi.varinder@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Care Hospital |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
|
|
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or non-pregnant, non-breastfeeding female ≥18 years of age
2. Rutherford Clinical Category 2-5
3. Patients who treated with at least one Peripherics paclitaxel-coated balloon catheter in superficial femoral and/or popliteal arteries as described in the Instruction for Use (IFU)
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 > 30 days prior-index procedure
|
|
| 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. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure
4. Previously implanted stent in target lesion(s)
5. Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
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 |
| Freedom from MAE |
6 months, and 12 months |
| Primary patency |
6 months, and 12 months |
| All-cause mortality |
6 months, and 12 months |
| Major target limb amputation |
6 months, and 12 months |
| CD-TLR |
6 months, and 12 months |
| Change in mean Ankle Brachial Index (ABI) compared to the pre-procedure |
30 days, 6 months, and 12 months |
| Improvement in Rutherford classification compared to the pre-procedure |
30 days, 6 months, and 12 months |
| Amputation-free survival (AFS) including major, minor, and overall AFS |
30 days, 6 months, and 12 months |
| Device success |
Immediately upon procedure |
| Technical success |
Immediately upon procedure |
| Procedural success |
Immediately upon discharge |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is a retrospective, observational, multicenter, single arm, investigator initiated, post-market study, designed to assess the clinical safety and performance of Peripherics paclitaxel-coated balloon catheter in SFA and/or PA during routine clinical practice. All consecutive patients, with claudication or ischemic rest pain and documented diagnosis of peripheral arterial disease in SFA and/or PA classified as Rutherford class 2-5, either who had been treated with Peripherics paclitaxel-coated balloon catheter at least 6 months prior or who will be treated with Peripherics paclitaxel-coated balloon catheter within 6 months after the starting date of the retrospective anonymous data collection will be included in this study. This study has been designed for academic research purpose only and has no impact on the patient’s routine standard of care. |