CTRI Number	CTRI/2016/11/007473 [Registered on: 17/11/2016] Trial Registered Prospectively
Last Modified On:	17/06/2019
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Medical Device
Study Design	Single Arm Study
Public Title of Study Modification(s)	To evaluate safety and performance of CREDENCE™ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemia following Percutaneous Transluminal Angioplasty of below the knee arteries.
Scientific Title of Study	A prospective, multicentre and open label clinical study to evaluate safety and performance of CREDENCE™ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemia following Percutaneous Transluminal Angioplasty of below the knee arteries.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  MLS/ CREDENCE™ BtK – 1/V 1.0.0/20/04/2016  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Gireesh Warawdekar  Address  St Andrews Road, Hill Road, Near St Peter;s church. Bandra west, Mumbai, Maharashtra, 400050 Mumbai MAHARASHTRA 400050 India  Phone     Fax     Email  gireesh.w@gmail.com
Details Contact Person Scientific Query	Name  Dr Gireesh Warawdekar  Address  St Andrews Road, Hill Road, Near St Peter;s church. Bandra west, Mumbai, Maharashtra, 400050 Mumbai MAHARASHTRA 400050 India  Phone     Fax     Email  gireesh.w@gmail.com
Details Contact Person Public Query	Name  Dr Ashok Thakkar  Address  Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi – 396191, Gujarat, India Valsad GUJARAT 396191 India  Phone     Fax     Email  ashok.thakkar@merillife.com
Source of Monetary or Material Support	Meril Life Sciences Pvt Ltd
Primary Sponsor	Name  Meril Life Sciences Pvt Ltd  Address  Meril Life Sciences Pvt. Ltd. Survey No.135, 139 Bilakhia House Muktanand Marg Chala Vapi – 396191 Gujarat, India   Type of Sponsor  Other [Medical Device Company]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 15   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Pankaj J Banode  Acharya Vinoba Bhave Rural Hospital  Department of Cardiology, Wardha-442004, Maharashtra, India Wardha   9960713020 drpjbanode@gmail.com  Dr Sanjiv Sharma  All India Institute of Medical Sciences  Department of Cardiology, Ansari Nagar, New Delhi 110029, Delhi, India New Delhi   9868398119 meetisv@yahoo.com  Dr Shrikaant Kothekar  Arneja Heart and Multispecialty Hospital  Department of Cardiology, Plot No 123, Behind Somalwar High School, Ramdaspeth, Nagpur-440010, Maharashtra, India Nagpur   9823083368 drshrikaantkothekar@gmail.com  Dr P C Gupta  CARE Hospitals  Department of Cardiology , Road No. 1, Prem Nagar, Banjara Hills, Hyderabad - 500034, Telangana, India Hyderabad   9848053220 pcgupta10@hotmail.com  Dr Guruprasad Naik  Goa Medical College  Department of Cardiology, Goa Medical College and Hospital, District, Panaji 403202, Goa, India North Goa   9763343842 gurunaik@hotmail.com  Dr Sanjay Tyagi  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research  Department of Cardiology, 1, Jawaharlal Nehru Marg, New Delhi, Delhi 110002, India New Delhi   9891356668 drsanjaytyagi@yahoo.com  Dr Tarun Madan  HCG Hospitals  Department of Cardiology, Mithakhali Six Road, Ellis Bridge, Ahmedabad-380006, Gujarat, India Ahmadabad   9824743624 drtarunmadan@yahoo.co.in  Dr N N Khanna  Indraprastha Apollo Hospitals  Department of Cardiology, Indraprastha Apollo Hospitals, Room No 1037, Sarita Vihar, Near Jasola Apollo Hospital, Mathura Road, New Delhi, India New Delhi   9810494072 drnnkhannaoffice@gmail.com  Dr Vimal Someshwar  Kokilaben Dhirubhai Ambani Hospital and Medical Research  Department of Cardiology, Kokilaben Dhirubhai Ambani Hospital and Medical Research, Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai 400053, Maharashtra, India Mumbai   919820064685 drvimal.pulseclinic@gmail.com  Dr Vivek Ukirde  Lokmanya Tilak Municipal Medical College and General Hospital  Department of Cardiology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, India Mumbai   9869335336 dhruvrays@hotmail.com  Dr Sanjay Desai  M S Ramaiah Memorial Hospital  Department of Cardiology, M S Ramaiah Memorial Hospital, New B E L Road, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054, Karnataka, India Bangalore   9845290575 scdesai@hotmail.com  Dr Bharat Bhushan Chanana  Maharaja Agrasen Hospital  Department of Cardiology, Maharaja Agrasen Hospital, West Punjabi Bagh, Near MGS Hospital, New Delhi 110026, Delhi, India New Delhi   9810109195 bbchanana@yahoo.com  Dr Kumud Rai  Max Super Speciality Hospital  Department of Cardiology, 2 Press Enclave Road, Saket, New Delhi-110017, India New Delhi   9810205525 Kumud.rai@maxhealthcare.com  Dr Viveka Kumar  Max Super Speciality Hospital  Department of Cardiology, Max Super Speciality Hospital (a unit of Devki Devi Foundation), 1 Press Enclave Road, Saket , New Delhi 110017, Delhi, India New Delhi   911126515050 viveka.kumar@maxhealthcare.com  Dr Dhanesh Kamrekar   Ruby Hall Clinic   Department of Cardiology, Ruby Hall Clinic, 40, Sassoon Road, Pune 411001, Maharashtra, India Pune   9822041808 dhaneshkamerkar@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 15   Name of Committee  Approval Status  Arnejas Institutional Ethics Committee, Nagpur   Approved  Institutional Ethics Committee, AIMS, New Delhi  Approved  Institutional Ethics Committee, Care Hospital, Banjarahills  Approved  Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences, Maharashtra  Approved  Institutional Ethics Committee, Goa Medical College, Goa, India  Approved  Institutional Ethics Committee, HCG Hospitals, Ahmedabad  Approved  Institutional Ethics Committee, Human Research -Lokmanya Tilak Municipal Medical College, Mumbai, India  Approved  Institutional Ethics Committee, Indraprastha Apollo Hospitals, New Delhi, India  Approved  Institutional Ethics Committee, Maharaja Agrasen Hospital, New Delhi, India  Approved  Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospital, New Delhi   Approved  Institutional Ethics Committee, Max Healthcare, New Delhi, India  Approved  Institutional Ethics Committee, Max Super Specialty Hospital, New Delhi, India  Approved  Institutional Ethics Committee, Poona Medical Research Foundation, Pune, India  Approved  Institutional Review Board, M S Ramaiah Medical College and Hospitals, Banglore, India  Approved  Institutional Scientific and Ethics Board, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai, India  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Peripheral vascular disease, unspecified
Intervention / Comparator Agent	Type  Name  Details  Intervention  CREDENCE™ BtK  Sirolimus Eluting BioResorbable Peripheral Scaffold System  Comparator Agent  NIL  NIL
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  1. Stenotic (greater than 50 percent) or occlusive atherosclerotic disease of the below the knee arteries. 2. Length of lesion less than or equal to 56 milimeter. 3. Reference vessel diameter 2.25–4.50 milimeter. 4. A maximum of two lesions in one below the knee vessel treated in the study, or in two vessels of two different legs. 5. Symptomatic Critical Limb Ischemia (Rutherford 4 and 5) 6. Life expectancy of greater than 6 months 7. No child-bearing potential or negative pregnancy test within 7 days of the index procedure. 8. Patient willing and able to return at the appropriate followup times for the duration of the study. 9. Patient provision of written patient informed consent that is approved by the ethics committee.
ExclusionCriteria	Details  1. Patient refusing treatment. 2. Reference segment diameter not suitable for available scaffold design. 3. Length of lesion requiring more than one scaffold implantation. 4. Previously implanted stent(s) or PTA at the same lesion site. 5. Lesion lying within or adjacent to an aneurysm. 6. Inflow-limiting arterial lesions left untreated. 7. Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses, or is unable, or unwilling, to tolerate such therapies. 8. Patient taking phenprocoumon (Marcumar) 9. Patient history of prior life-threatening contrast medium reaction. 10. Patient currently enrolled in another investigational device or drug trial. 11. Patient currently breastfeeding, pregnant, or intending to become pregnant. 12. Patient mentally ill or retarded.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  The primary objective of the CREDENCE™ BtK-1 study is to evaluate safety and performance of the CREDENCE™ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subject with Critical Limb Ischemia disease due to de novo lesions (length ≤56mm) in below the knee arteries  Clinical follow-up at post-procedure 1day, 1 month ± 15 days, 6 months ± 28 days, & 12 months ± 28 days, 2 Year ± 28 days, 3 Year ± 28 days, 4 Year ± 28 days, 5 Year ± 28 days.
Secondary Outcome	Outcome  TimePoints  Late Lumen Loss (LLL) as diagnosed at 6-month angiographic follow-up  6 Months
Target Sample Size	Total Sample Size="30" Sample Size from India="30"
Phase of Trial Modification(s)	Phase 3
Date of First Enrollment (India) Modification(s)	21/11/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	not yet published
Brief Summary	Credence BtK - 1 is a prospective, multicentre and open label clinical study to evaluate safety and performance of CREDENCE™ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemia following Percutaneous Transluminal Angioplasty of below the knee arteries. The purpose of this study is to evaluate safety and performance of the CREDENCE™ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subject with Critical Limb Ischemia disease due to de novo lesions (length ≤56mm) in below the knee arteries with a reference vessel diameter of 2.25 mm to 4.50 mm in patients eligible for Percutaneous Transluminal Angioplasty (PTA) and stenting.