| CTRI Number |
CTRI/2015/11/006374 [Registered on: 20/11/2015] Trial Registered Prospectively |
| Last Modified On: |
10/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Medical Device] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post-market study of the Zilver PTX Stent in patients with blocked arteries of the leg. |
|
Scientific Title of Study
|
A prospective, phase 4, open label, multicenter study to evaluate the Zilver PTX Drug-Eluting Peripheral Stent in patients with lesions of the above-the-knee femoropopliteal artery in India ( Zilver PTX VII,India) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shoaib Mohammad |
| Designation |
Medical Director |
| Affiliation |
INC Research CDS Services Pvt. Ltd. |
| Address |
Building No 14, Tower B, 14th Floor DLF Cyber City, Phase III
Gurgaon, India
Gurgaon
HARYANA
122001
India |
| Phone |
9818587766 |
| Fax |
01244642401 |
| Email |
Shoaib.Mohammad@INCResearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoaib Mohammad |
| Designation |
Medical Director |
| Affiliation |
INC Research CDS Services Pvt. Ltd. |
| Address |
Building No 14, Tower B, 14th Floor DLF Cyber City, Phase III
Gurgaon, India
Gurgaon
HARYANA
122001
India |
| Phone |
9818587766 |
| Fax |
01244642401 |
| Email |
Shoaib.Mohammad@INCResearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Abhishek Tyagi |
| Designation |
Director, Clinical Operations |
| Affiliation |
Kendle India Pvt. Ltd |
| Address |
Building No 14, Tower B, 14th Floor DLF Cyber City, Phase III
Gurgaon, India
Gurgaon
HARYANA
122001
India |
| Phone |
01244642400 |
| Fax |
01244642401 |
| Email |
abhishek.tyagi@incresearch.com |
|
|
Source of Monetary or Material Support
|
| Cook Incorporated, 750 Daniels Way
Bloomington, IN 47404
USA, and
Cook India Medical Devices Pvt Ltd,
4/249A, Rasim Enclave, Poonamallee High Road,
Goparasanallur, Kattupakkam,
Chennai - 600056. Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Cook Incorporated |
| Address |
750 Daniels Way
Bloomington, IN 47404
USA |
| Type of Sponsor |
Other [Medical Devices Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Cook India Medical Devices Pvt Ltd |
4/249A, Rasim Enclave, Poonamallee High Road,
Goparasanallur, Kattupakkam,
Chennai - 600056. Tamil Nadu, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr George Joseph |
Christian Medical College |
Department of Cardiology, Ida Scudder Road, Vellore - 632001
Vellore
TAMIL NADU |
04162282631
04162232935
joseph59@gmail.com |
| Dr Vivek Chaturvedi |
Govind Ballabh Pant Hospital |
Department of Cardiology, Room No. 124 Academic Block, G. B. Pant Hospital, Jawahar Lal Nehru Marg,New Delhi - 110002
India
New Delhi
DELHI |
9718599111
01123239442
dr_vchaturvedi@yahoo.com |
| Dr Rajiv Parakh |
Medanta - The Medicity |
Medanta Division of Peripheral Vascular and Endovascular
Sciences, Medanta-The Medicity, Sector 38,
Gurgaon
Gurgaon
HARYANA |
9811047390
01244834468
rajiv.parakh@medanta.org |
| Dr Dhanesh Ravindra Kamerkar |
Ruby Hall Clinic |
Department of Vascular and Endovascular Surgery, 40, Sassoon Road, Pune – 411001,
Mahrashtra, India
Pune
MAHARASHTRA |
02066455495
02066455628
dhaneshkamerkar@gmail.com |
| Dr Varinder Singh Bedi |
Sir Ganga Ram Hospital |
Department of Cardiology, Sir Ganga Ram Hospital, Old Rajinder Nagar
New Delhi
DELHI |
9968094990
01142437230
bedi.varinder@gmail.com |
| Dr Tarun Madan |
U. N. Mehta Institute of Cardiology and Research Centre |
Department of Cardiology, (Affiliated to B. J. Medical College, Ahmedabad)
B. J. Medical College & Civil Hospital Campus, Asarwa
Ahmadabad
GUJARAT |
9824743624
drtarunmadan@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,B. J. Medical College and Civil Hospital Ahmedabad |
Not Applicable |
| Institutional Ethics Committee- Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee-MAMC |
Approved |
| Institutional Review Board-CMC vellore |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paitent with lesions of the above-the-knee femoropopliteal artery due to peripheral artery disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Zilver PTX Drug-Eluting Peripheral Stent |
The Zilver PTX stent is intended for use in the treatment of symptomatic vascular disease
of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4
mm to 9 mm.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptoms of peripheral arterial disease corresponding to Rutherford
Classification 2-4
2. Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee
femoropopliteal artery
3. Reference vessel diameter of 4-7 mm |
|
| ExclusionCriteria |
| Details |
1. Less than 18 years old
2. Unwilling or unable to sign and date the informed consent
3. Pregnant, lactating, or planning to become pregnant in the next 5 years
4. Unwilling or unable to comply with follow-up schedule
5. Simultaneously participating in another investigational drug or device study in which the follow-up phase for that study’s primary endpoint has not been completed 30 days or more prior to being enrolled in this study.
6. Presence of study limb wound (Rutherford Classification 5-6)
7. Any interventional treatment within 30 days prior to the study procedure
8. Planned surgical or interventional procedure within 30 days after the study procedure
9. Planned procedure involving arterial interventional treatment of the study leg
within 6 months after the clinical study procedure
10. Medical condition or disorder that would limit life expectancy to less than 12
months, or that may cause noncompliance with the study plan or confound the data analysis
11. Known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated; study products include nitinol, paclitaxel, dual antiplatelet therapy, and contrast agent
12. Current systemic or local infection that could affect the study outcomes
13. Previous stent in the target vessel
14. Bypass graft with an anastomosis in the target vessel
15. Myocardial infarction within the last 90 days
16. Is in chronic renal failure, or is on hemodialysis or chronic peritoneal dialysis
17. Uncontrolled or poorly controlled diabetes
18. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
19. History of aortic aneurysm 5 cm (treated or untreated)
20. History of iliac aneurysm 2 cm (treated or untreated).
21. Lesion length 140 mm
22. Untreated stenosis ( 50%) or occlusion of inflow tract (i.e., proximal ipsilateral,
iliofemoral, or aortic lesions). Inflow tract may be treated during the study procedure.
23. Untreated stenosis ( 50%) or occlusion of all runoff vessels (i.e., anterior tibial,
posterior tibial and peroneal). Runoff vessel(s) may be treated during the study
procedure; treatment must be performed prior to treating the target lesion and
result in less than eqal to 30% residual stenosis of at least one runoff vessel.
24. Angiographically-evident thrombus in the target lesion
25. Lesions requiring atherectomy (or ablative devices), cutting balloons, or any
other advanced device to facilitate stent delivery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related
major adverse events (death, amputation of the study limb due to target lesion restenosis,
clinically driven target lesion revascularization, target limb ischemia requiring surgical
intervention due to target lesion restenosis, or surgical repair of the target vessel due to
target lesion restenosis). |
6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| 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)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This multicenter, prospective, single-arm clinical study will evaluate the Zilver PTX Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in an Indian patient population. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery and the popliteal artery above the plane of the femoral epicondyles. The primary endpoint will be 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related major adverse events (death, amputation of the study limb due to target lesion restenosis, clinically driven target lesion revascularization, target limb ischemia requiring surgical intervention due to target lesion restenosis, or surgical repair of the target vessel due to target lesion restenosis). |