Prospective, multicentre, non- interventional, observational, data collection registry
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
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
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
Dr Krantikumar Rathod
King Edward Memorial Hospital
Acharya Donde Marg, Parel,
Mumbai 400 012, Maharastra. Mumbai MAHARASHTRA
Dr Vimal Someshwar
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Kokilaben Dhirubhai Ambani Hospital and Medical
Rao saheb Achutrao Patwardhan Marg, Four
Bunglows Andheri West Mumbai Mumbai City
Maharashtra - 400053 India Mumbai MAHARASHTRA
Dr Mathew Cherian
Kovai Medical Center and Hospital
99, Avinashi Rd, Peelamedu, Indira Nagar, Civil Aerodrome Post, Coimbatore, Tamil Nadu 641014 Coimbatore TAMIL NADU
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
Dr Vivek Ukirde
Lokmanya Tilak Municipal General Hospital
Dr Babasaheb Ambedkar Rd, RB2 Central Railway Quarters, Sion West, Sion, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA
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.
Dr Venkatesh Reddy K
Manipal Hospital, #98, HAL Airport Road, Bangalore-560017, Karnataka, India. Bangalore KARNATAKA
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
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
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
Dr Rajiv Parakh
Medanta - The Medicity
Division of Peripheral Vascular and
CH Baktawar Singh Road, Sector 38,
Gurugram, Haryana 122001 Gurgaon HARYANA
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
Dr Vikash Jain
NM Virani Wockhardt Hospital
NM Virani Wockhardt Hospital, Kalawad Road, Near St. Marys High School, Rajkot, Gujarat 360007, India. Rajkot GUJARAT
Dr Dhanesh Kamerkar
Ruby Hall Clinic
Grant Medical Foundation, Ruby Hall Clinic,
40,Sassoon road, Pune, Maharashtra - 411001 India Pune MAHARASHTRA
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.
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.
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
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"
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 Population - An estimated 500 eligible patients are planned to be enrolled from 25 centres across India
6.Gökgöl C, Schumann S, Diehm 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.
17.Myint M, Schouten O, Bourke V, et al. A real-worldexperience with the Superainterwovennitinolstent in femoropopliteal arteries: Midtermpatencyresults and failureanalysis. J EndovascTher. 2016;23(3):433-41.
19.Scheinert D, Werner M, Scheinert S, et al.Treatment of complexatheroscleroticpoplitealarterydisease with a newself-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA poplitealartery stent registry. JACC Cardiovasc Interv. 2013;6(1):65-71.
20.Chan YC, Cheng SW, Ting AC, et al. Primarystenting of femoropopliteal atherosclerotic lesions using newhelical interwovennitinol stents. J Vasc Surg.2014;59(2):384-91.