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CTRI Number  CTRI/2019/09/021451 [Registered on: 30/09/2019] Trial Registered Prospectively
Last Modified On: 01/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study
Modification(s)  
Prospective, multicentre, non- interventional, observational, data collection registry 
Study Design  Other 
Public Title of Study   Real-World, Registry to Evaluate the Effectiveness, Safety and Durability of SUPERA Stent for the Treatment of De Novo or Restenotic Superficial Femoral Artery or Complex Femoropopliteal Artery Lesions 
Scientific Title of Study
Modification(s)  
A Prospective, Multicentric, Non- Interventional Real-World, Data Collection Registry to Evaluate the Effectiveness, Safety and Durability of SUPERA Stent for the Treatment of De Novo or Restenotic Superficial Femoral Artery or Complex Femoropopliteal Artery Lesions in Indian patients 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
iSUPREME/01/2019_Version Number 1.1 & dated 03 Jan 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Parakh 
Designation  Chairman 
Affiliation  Medanta - The Medicity 
Address  Division of Peripheral Vascular and Endovascular Sciences, CH Baktawar Singh Road, Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9811047390  
Fax    
Email  parakhsupreme@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajiv Parakh 
Designation  Chairman 
Affiliation  Medanta - The Medicity 
Address  Division of Peripheral Vascular and Endovascular Sciences, CH Baktawar Singh Road, Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9811047390  
Fax    
Email  parakhsupreme@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajiv Parakh 
Designation  Chairman 
Affiliation  Medanta - The Medicity 
Address  Division of Peripheral Vascular and Endovascular Sciences, CH Baktawar Singh Road, Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9811047390  
Fax    
Email  parakhsupreme@gmail.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Pvt Ltd, Office Floor, The Suryaa Hotel, New Friends Colony, Mathura Road, New Delhi, Delhi 110025 
 
Primary Sponsor
Modification(s)  
Name  Dr Rajiv Parakh  
Address  Chairman, Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Near Olympus, CH Baktawar Singh Rd, Sector 38, Gurugram, Haryana 122001 
Type of Sponsor  Other [ ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 25  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manas Ranjan Kar  Apollo Hospitals  plot no 251, Sainik School Rd, Unit 15, Gajapati Nagar, Bhubaneswar, Odisha 751005

 
8599009292

dr.manaskar@gmail.com 
Dr Sunder Narasimhan  Apollo Hospitals  154, IIM, 11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Nagar, Naga, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA 
7760353187

supriarvind@yahoo.co.in 
Dr P C Gupta  Care Hospitals  Consultant Vascular Surgeon,Care Hospitals , Road No 10, Near Rainbow Hospitals, Banjara Hills, Hyderabad, Telangana 500034, India
Hyderabad
TELANGANA 
9666088000

vasculartherapy@gmail.com 
Dr Abhijit Soni  Dr L.H.Hiranandani Hospital  HBOT Department, Dr. LH Hiranandani Hospital, Powai, Mumbai, Maharashtra 400076
Mumbai
MAHARASHTRA 
9821014778

drabhijitsoni@gmail.com 
Dr Vivekanand  Jain Institute Of Vascular Sciences, A Unit Of Bhagwan Mahaveer Jain Hospital  Division of Vascular surgery 17, Millers Road, Kaverappa Layout, Vasanth Nagar, Bengaluru, Karnataka 560052
Bangalore
KARNATAKA 
9844036412

vivsvas@hotmail.com 
Dr Krantikumar Rathod  King Edward Memorial Hospital  Acharya Donde Marg, Parel, Mumbai 400 012, Maharastra.
Mumbai
MAHARASHTRA 
9820077238

krantikumarrathod@gmail.com 
Dr Vimal Someshwar  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao saheb Achutrao Patwardhan Marg, Four Bunglows Andheri West Mumbai Mumbai City Maharashtra - 400053 India
Mumbai
MAHARASHTRA 
9820064685

someshwarvimal@gmail.com 
Dr Mathew Cherian  Kovai Medical Center and Hospital  99, Avinashi Rd, Peelamedu, Indira Nagar, Civil Aerodrome Post, Coimbatore, Tamil Nadu 641014
Coimbatore
TAMIL NADU 
9600900373

dr.mathewcherian@gmail.com 
Dr Gireesh Warawdekar  Lilavati Hospital and Research Centre  Lilavati Hospital and Research Centre, A-791, Bandra Reclamation Road, Bandra West, Mumbai, Maharashtra 400050, India
Mumbai
MAHARASHTRA 
9820053028

gireesh.w@gmail.com 
Dr Vivek Ukirde  Lokmanya Tilak Municipal General Hospital  Dr Babasaheb Ambedkar Rd, RB2 Central Railway Quarters, Sion West, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA 
9326079909

druvrays@gmail.com 
Dr Sanjay C Desai  M.S.Ramaiah Medical College and Hospitals  M.S.Ramaiah Medical College and Hospitals, M.S.Ramaiah Nagar, MSRIT Post, Bangalore-560054.
Bangalore
KARNATAKA 
9845290575

scdesai@hotmail.com 
Dr Venkatesh Reddy K  Manipal Hospital  Manipal Hospital, #98, HAL Airport Road, Bangalore-560017, Karnataka, India.
Bangalore
KARNATAKA 
9880311511

venkatesh.reddy@manipalhospitals.com 
Dr Digvijay Sharma  Max Super Speciality Hospital  Principal Consultant-Vascular surgery department, Max Super Speciality Hospital, Shalimar Bagh, FC-50 C & D Block, Shalimar Bagh, New Delhi-110088. India.
New Delhi
DELHI 
9311003130

digvijay@professordigvijay.com 
Dr Kapil Gupta  Max Super Speciality Hospital  Senior Consultant and in-charge(Vascular and Endovascular Surgery), Max Super Specialty Hospital, Vaishali A Unit of Crosslay Remedies Ltd, W-3, Sector-1, Vaishali, Ghaziabad-201012, Uttar Pradesh, India.
Ghaziabad
UTTAR PRADESH 
9818393071

drkapil_gupta@yahoo.com 
Dr Kumud Rai  Max Super Speciality Hospital (A unit of Devki Devi Foundation)  Director, Vascular surgery, Max Super Speciality Hospital, (A unit of Devki Devi Foundation) 2 Press Enclave Road,Saket, New Delhi – 110017 India
New Delhi
DELHI 
9810205525

kumud.rai@maxhealthcare.com 
Dr Rajiv Parakh  Medanta - The Medicity  Division of Peripheral Vascular and Endovascular Sciences, CH Baktawar Singh Road, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA 
9811047390

parakhsupreme@gmail.com 
Dr Robbie George  Narayana Institute of Cardiac Sciences  Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area Anekal Taluk, Hosur Rd, Bengaluru-560099, Karnataka, India.
Bangalore
KARNATAKA 
9538896751

drrobbiegeorge@gmail.com 
Dr Vikash Jain  NM Virani Wockhardt Hospital  NM Virani Wockhardt Hospital, Kalawad Road, Near St. Marys High School, Rajkot, Gujarat 360007, India.
Rajkot
GUJARAT 
9033004666

vikashrjain007@gmail.com 
Dr Dhanesh Kamerkar  Ruby Hall Clinic  Grant Medical Foundation, Ruby Hall Clinic, 40,Sassoon road, Pune, Maharashtra - 411001 India
Pune
MAHARASHTRA 
9822041808

dhaneshkamerkar@gmail.com 
Dr Rahul Sheth  S L Raheja Hospital  Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra 400016
Mumbai
MAHARASHTRA 
9820082754

rahulsheth1@gmail.com 
Dr Varinder Singh Bedi  Sir Ganga Ram Hospital  Chairman, Institute of Vascular & Endovascular Sciences,Sir Ganga Ram Hospital, Sarhadi Gandhi Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi-110060
New Delhi
DELHI 
9560194900

bedi.varinder@gmail.com 
Dr Muralikrishna N  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta road, Jayanagar 9th block, Bangalore-560069.
Bangalore
KARNATAKA 
9880133066

drmurali1978@yahoo.co.in 
Dr Radhakrishnan R  Sri Ramachandra Institute of Higher Education and Research  Professor of Vascular surgery, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India
Chennai
TAMIL NADU 
9840073083

rrkrishnan@hotmail.com 
Dr R Ravi kumar  Thambiran Heart And Vascular Institute  36, Q-Block, 17th Street, Anna Nagar, Chennai, Tamil Nadu 600040
Chennai
TAMIL NADU 
9884014679

hemarrk@yahoo.co.uk 
Dr Vijay Thakore  Vadodara Institute of Neurological Sciences  Vadodara Institute of Neurological Sciences (VINS Hospital), 99-Urmi society, Opposite Haveli, Productivity Road, Alkapuri, Vadodara -390007, India.
Vadodara
GUJARAT 
9825028114

vijaythakore67@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 25  
Name of Committee  Approval Status 
Poona Medical Research Foundation, Institutional Ethics Committee  Approved 
Care Hospital Institutional Ethics committee  Approved 
Clinicom independent ethics committee Bangalore  Approved 
Ethics Committee of Manipal Hospitals  Approved 
Ethics committee Prof M Viswanathan Diabetes Research Centre  Approved 
Ethics Committee-Kovai Medical Center and Hospital  Approved 
Institutional Ethics Committee - BMR of Apollo Hospitals, Bangalore  Approved 
Institutional Ethics Committee - Fortis Hospital Shalimar Bagh, New Delhi  Approved 
Institutional Ethics Committee - SGPGIMS, Lucknow  Approved 
Institutional Ethics Committee Human Research LTMGH and LTMMC  Submittted/Under Review 
Institutional Ethics Committee Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Institutional Ethics Committee Max Super Specialty Hospital, Vaishali  Approved 
Institutional Ethics committee, Bhagwan Mahaveer Jain Hospital  Approved 
Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research  Approved 
Institutional Ethics Committee-Lilavati Hospital and Research Center  Approved 
KIMS HEALTH Institutional Human Ethics Committee  Submittted/Under Review 
Max Healthcare Ethics Committee  Approved 
Max Super Speciality Hospital (A unit of Devki Devi Foundation) Institutional Ethics Committee  Submittted/Under Review 
Medanta Institutional Ethics Committee   Approved 
Narayana Health Medical Ethics Committee  Approved 
Shree Giriraj Hospital Research Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
Sri Jayadeva Ethics Committee  Approved 
VINS Ethics Committee  Approved 
Vision Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged ≥18 years.
2. Patients willing to sign the informed consent form (ICF) to share the data.
3. Patients with de novo or restenotic lesions in the superficial femoral artery or femoropopliteal segment treated successfully (<30% diameter stenosis with no procedural complications) with SUPERA stent.  
 
ExclusionCriteria 
Details  1. Patients unwilling to sign the ICF.
2. Patients with age <18 years or >90 years.
3. Patients with other comorbidities that may limit life expectancy to less than one year. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1. Percentage of patients free from TLR at 12 months after the index intervention   12 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Percentage of patients with a patent index vessel at 12 months,
Percentage of patients who died from any cause (all-cause death),
Percentage of patients with stent fractures on radiographic screening at 12 months after the index procedure,
Change in clinical status of the patient (assessed by Rutherford-Becker classification) from baseline, at 12 months after the index intervention,
Change in quality of life from baseline to 12 months after the index intervention  
12 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)
Modification(s)  
22/06/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background/Rationale:

Guidelines for the management of peripheral artery diseases recommend endovascular therapy as a reasonable option for the treatment of femoropopliteal artery (FPA) lesions.1,2 However, one of the potential challenges during endovascular procedures of FPA is the difficulty in achieving long-term patency and durability of the implanted stents, due to the unique anatomy and deformations of FPA during limb flexion.3-5 Stenting of FPA may restrict the shortening capabilities of the artery, leading to kinking during leg flexion, which when coupled with stent fractures formed during leg flexion, may result in restenosis and reduced patency rates.6,7

 One of the factors determining the extent of damage caused to the FPA and stent during endovascular procedures is the mechanical characteristics of the stent.8 Self-expanding nitinol stents have been proven to be a preferred choice over balloon expandable stents for treating FPA lesions due to their high radial strength and flexibility, reduced foreshortening, ability to recover after being crushed, and deployability without balloon dilation of the stent edge.9Nitinol is a highly elastic alloy with unique thermal-shape memory and mechanical properties that render it resilient and durable. Variations in the manufacturing processes of nitinol stents may affect the microstructure of the alloy, the stent design and subsequently the mechanical properties of the stents.8 Hence, different designs of self-expanding nitinol stents may affect limb flexion-induced deformations in the FPA in different ways.10,11

 The SUPERA Peripheral Stent System is an interwoven self-expanding nitinol stent that has high flexibility, radial strength, and resistance to kinking and fractures.12-14 The efficacy, safety and durability of SUPERA for the treatment of FPA lesions, including long and complex lesions, has been clinically proven in the SUPERB trial through 3 years of follow-up,14,15 and other retrospective and prospective real-world studies.16-23

 Although SUPERA has been available for commercial use in India for the last few years, nevertheless, there have been no studies till date, assessing the safety and effectiveness of SUPERA stent in Indian patients with FPA disease. The Indian clinical scenario for the management of peripheral vascular disease may be different from the West, due to low disease awareness, late presentation, delays in diagnosis, therapy cost and access issues, and lack of national registries.24,25

 In view of this background, there is a crucial unmet need: (1) to understand the clinical presentation of FPA disease in patients with symptomatic lower extremity disease, and (2) to evaluate the safety and effectiveness outcomes of SUPERA stent in these patients in a real-world Indian scenario. Further, there is also a need to understand the various predicting factors for restenosis after endovascular treatment of FPA lesions, as literature is limited to very few studies outlining the role of lesion length and lesion severity in predicting outcomes after stenting of FPA lesions.26-29

Study Design – Prospective, multicentre, non-interventional, observational, data collection registry 

Study PopulationAn estimated 500 eligible patients are planned to be enrolled from 25 centres across India  


 References:


1.      Aboyans V, Ricco JB, Bartelink MEL, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS).Rev EspCardiol (Engl Ed). 2018;71(2):111. 

2.      Writing Committee Members, Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the management of patients with lower extremity peripheral artery diseaseExecutive summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.Circulation. 2017;135(12):e686–e725.

3.      Bajzer CT. Arterial supply of the lower extremities. Available at: https://www.ncbi.nlm.nih.gov/books/NBK27342/. Accessed on: 12 Mar 2019.

4.      Watt JK. Origin of femoro-popliteal occlusions. Brit Med J.1965;2:1455-1459.

5.      Desyatova APoulson WDeegan Pet al.Limb flexion-induced twist and associated intramural stresses in the human femoropopliteal artery. J R Soc Interface. 2017;14(128).

6.      Gökgöl CSchumann SDiehm N, et al.In vivo quantification of the deformations of the femoropopliteal segment: Percutaneous transluminal angioplasty vs nitinol stent placement. J EndovascTher. 2017;24(1):27-34.

7.      Scheinert DScheinert SSax J, et al.Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312-5.

8.      Maleckis KAnttila EAylward Pet al. Nitinol stents in the femoropopliteal artery: A mechanical perspective on materialdesign, and performance. Ann Biomed Eng. 2018;46(5):684-704.

9.      Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J EndovascTher. 2009;16(2 Suppl 2):II63-81.

10.  MacTaggart JPoulson WSeas Aet al.Stent design affects femoropopliteal artery deformation. Ann Surg. 2018. doi: 10.1097/SLA.0000000000002747.

11.  Maleckis KDeegan PPoulson Wet al. Comparison of femoropopliteal artery stents under axial and radial compressionaxialtensionbending, and torsion deformation. J Mech Behav Biomed Mater. 2017;75:160-168.

12.  SUPERA Instructions for Use. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120020c.pdf. Accessed on: 12 Mar 2019.

13.  Bishu KArmstrong EJ. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: A review of the clinical evidence. Vasc Health Risk Manag. 2015;11:387-95.

14.  Garcia LJaff MRMetzger Cet al.Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: Twelve-month results of the SUPERB trial. Circ Cardiovasc Interv. 2015;8(5). pii: e000937.

15.  Garcia LARosenfield KRMetzger CD, et al.SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv. 2017;89(7):1259-1267.

16.  Brescia AAWickers BMCorrea JC, et al.Stenting of femoropopliteal lesions using interwoven nitinol stents.J Vasc Surg. 2015;61(6):1472-8.

17.  Myint MSchouten OBourke V, et al.real-world experience with the Supera interwoven nitinol stent in femoropopliteal arteriesMidterm patency results and failure analysis. J EndovascTher. 2016;23(3):433-41.

18.  Scheinert DGrummt LPiorkowski M, et al.novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J EndovascTher. 2011;18(6):745-52.

19.  Scheinert DWerner MScheinert Set al.Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013;6(1):65-71. 

20.  Chan YCCheng SWTing AC, et al. Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents. J Vasc Surg. 2014;59(2):384-91.

21.  Werner MPaetzold ABanning-Eichenseer U, et al.Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stentMidterm results from the Leipzig SUPERA 500registry. EuroIntervention. 2014;10(7):861-8.

22.  León LR JrDieter RSGadd CL, et al.Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery. J Vasc Surg. 2013;57(4):1014-22.

23.  Montero-Baker MZiomek GJLeon L, et al. Analysis of endovascular therapy for femoropopliteal disease with the Supera stent. JVasc Surg. 2016;64(4):1002-8.

24.  Sekar N. Education in vascular surgery: Critical issues in India. J Vasc Surg. 2008;48(6 Suppl):76S-80S.

25.  Suresh KR. What Ails diagnosis of peripheral arterial disease/critical limb ischemia/critical limb-threatening ischemia in India? Indian J Vasc&Endovasc Surg. 2017;4(4):139-142.

26.  Pearce BJToursarkissian B. The current role of endovascular intervention in the management of diabetic peripheral arterial disease. Diabet Foot Ankle. 2012;3. doi: 10.3402/dfa.v3i0.18977.

27.  Chan YCCheng SWCheung GC.Predictors of restenosis in the use of helical interwoven nitinol stents to treat femoropopliteal occlusive disease. J Vasc Surg. 2015;62(5):1201-9.

28.  Park UJKim HTRoh YN.Factors affecting outcomes after endovascular treatment for femoropopliteal atherosclerotic lesions. Asian J Surg. 2019;42(1):209-216.

29.  Dohi TIida OSoga Yet al.Incidencepredictors, and prognosis of in-stent occlusion after endovascular treatmentwith nitinol stents for femoropopliteal lesions. J Vasc Surg. 2014;59(4):1009-1015.e1.

 
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