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CTRI Number  CTRI/2017/08/009322 [Registered on: 09/08/2017] Trial Registered Retrospectively
Last Modified On: 29/02/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Post Market Surveillance (PMS)registry of Yukon Choice PC ELITE/PLUS Coronary Stent System for Percutaneous Coronary Intervention in all comers Indian Population 
Scientific Title of Study   Post Market Surveillance (PMS)Registry of Yukon Choice PC ELITE OR PLUS Coronary Stent System for Percutaneous Coronary Intervention in all comers Indian Population  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rhea Sharma 
Designation  Manager-Clinical Initiatives 
Affiliation  translumina therapeutics lop 
Address  metro tower, lac, mor land, plot 1, japan nath madhok marg, pocket J , part 2, new rajender nagar, new delhi

Central
DELHI
110060
India 
Phone  01128742874  
Fax    
Email  rheasharma@translumina.in  
 
Details of Contact Person
Scientific Query  
Name  Rhea Sharma 
Designation  Manager-Clinical Initiatives 
Affiliation  translumina therapeutics lop 
Address  metro tower, lac, mor land, plot 1, japan nath madhok marg, pocket J , part 2, new rajender nagar, new delhi

Central
DELHI
110060
India 
Phone  01128742874  
Fax    
Email  rheasharma@translumina.in  
 
Details of Contact Person
Public Query  
Name  Rhea Sharma 
Designation  Manager-Clinical Initiatives 
Affiliation  translumina therapeutics lop 
Address  metro tower, lac, mor land, plot 1, japan nath madhok marg, pocket J , part 2, new rajender nagar, new delhi

Central
DELHI
110060
India 
Phone  01128742874  
Fax    
Email  rheasharma@translumina.in  
 
Source of Monetary or Material Support  
Translumina Therapeutics LLP Ground Floor, Metro Tower LSC MOR Land, New Rajendra Nagar New Delhi - 110060 
 
Primary Sponsor  
Name  TRANSLUMINA THERAPEUTICS LLP 
Address  METRO TOWER, LSC MOR LAND, POCKET 2, PLOT 1, NEW RAJENDER NAGAR, NEW DELHI 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Gupta  Bhagwan Mahavir Medica Superspeciality Hospital  Department of Cardiology Opp PHED Colony Bariatu Road Ranchi 834009
Ranchi
JHARKHAND 		 06516606060

drgupta645@yahoo.co.in 
Dr Satish Suryavanshi  Fortis Escorts Heart Center  Department of Cardiology Near Marhimata Mandir, Makhahaba, K. K. Road & Makahaba Road, Near Pandit Jawahar Lal Nehru Memorial Medical College, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH 		 8818890844

drsatish_suryavanshi@yahoo.co.in 
Dr Pranab Jyoti Bhattacharya  Gauhati Medical College  Department of Cardiology Gauhati Medical college & Hospital Assam 781032
Bongaigaon
ASSAM 		 03612529457

drpranabguwahati@gmail.com 
Dr S Natarajan  GKNM Hospital  Department of Cardiology 6327, Netaji road, Pappanaichen Palayam, Coimbatore 641302
Coimbatore
TAMIL NADU 		 9842206679

dr_snrcbe@yahoo.co.in 
Dr Suvir Gupta  Global Heart Institute  Department of Cardiology Shanti Madhuban Plaza, Delhi Gate, Agra 282002
Agra
UTTAR PRADESH 		 0730074447

suviricha@gmail.com 
Dr Anil Kumar  Grant Medical College  Department of Cardiology J J Marg, Nagpada-Mumbai Central Off Jijabhoy Road, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA 		 022-22006848

drkumaranil122@gmail.com 
Dr Bhanu Duggal  Grant Medical College  Department of Cardiology J J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA 		 02223735555

bhanuduggal2@gmail.com 
Dr Tarun Dave  Jivraj Mehta Hospital  Senior Consultant Cardiology Dr Jivraj Mehta Smarak Health Foundation Ahemdabad Gujarat
Ahmadabad
GUJARAT 		 07926639839

tarundave@gmail.com 
Dr B B Chanana  Maharaja Agarsen Hospital  Department of Intervention cardiology maharaja agrasen hospital, rohtak road, west punjabi bagh 110026
West
DELHI 		 9810109195

bbchanana@yahoo.com 
Dr S S Bansal  Metro Heart Institute with Multispeciality  Director Cardiology Sector 16 A Near Sunflag hospital, Faridabad, Haryana 121002
Faridabad
HARYANA 		 01294277777

drbansal@metrohospital.in 
Dr Nakul Sinha  Multi Centers Lucknow  Director Cardiology Divine Hospital Sahar Hospital Shekhar Hospital Viraj Khand 1 Gomti Nagar Lucknow 226016
Lucknow
UTTAR PRADESH 		 05222721991

sinha.nakul@gmail.com 
Dr G S Gill  Pragma Superspeciality Hospital  Department of Cardiology Namdev Marg, Bhatti road Bhatinda HO 151001
Bathinda
PUNJAB 		 09356115501

drgursewak@yahoo.co.in 
Dr Vinesh Jain  Pushpanjali Institute Agra  Pushpanjali Institute of Cardiac Sciences, Pushpanjali Palace Delhi gate Agra 282002
Agra
UTTAR PRADESH 		 08954893946

drvineshjain@hotmail.com 
Dr Mariappan  SPMM Hospital  Department of Cardiology 29 Cuddalore main Road, Ammaper, Salem Tamil Nadu 636003
Salem
TAMIL NADU 		 09994542967

drmariappanp@gmail.com 
Dr Kamaldeep Chawla  Sterling Hospital  HOD Cardiology Opp INOX Cinema Race Course Circle West Hari Nagar Vadodra Gurarat 390007
Vadodara
GUJARAT 		 02652354455

kychawla@rediffmail.com 
SRIDHAR KASTURI  Sunshine Hospital  Department of Intervention Cardiology Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana 500003
Hyderabad
ANDHRA PRADESH 		 04044550000

sridharkasturi@yahoo.com 
Dr Apurva Vasavada  Tristar Hospital  Senior Concultant Cardiology Opp. T & TV High School, Nanpura, Surat, Gujarat 395001
Surat
GUJARAT 		 2612200000

ak.vasavada@gmail.com 
Dr M Vijaya Kumar  Vijaya Hospital  168/169 Arcot Road, Somsundara Bharathi Nagar Vadapalani Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 04424815174

dr.m.vijayakumar@gmailc.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College Kanpur  Approved 
Good Society for Ethics Research  Approved 
Good Society for Ethics Research  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Apollo Hospital Gujarat  Approved 
Institutional Ethics Committee GKNM Hospital Coimbatore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients who are eligible for an Angioplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient ≥ 18 years old.
2. Patient was treated for percutaneous coronary(PCI).
3. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
4. Candidate was operated for coronary artery bypass graft (CABG) .
5. Stable angina pectoris (Canadian Cardiovascular Society – CCS-Class 1, 2, 3 or 4)or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ECG-TT, SPECT, Stress echocardiography or Cardiac CT).
6. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study). 
Angiographic Inclusion Criteria
1. Patient was treated for elective stenting of 1 or 2 stenotic lesions in a native coronary artery.
2. Reference vessel ≥ 2.0 mm and ≤ 4.0 mm in diameter by visual estimation.
3. Target lesion ≤ 40 mm in length by visual estimation (the intention should be to cover the whole lesion with maximum 2 stents of adequate length).
4. Protected left main lesion with >50% stenosis.
5. Target lesion stenosis ≥ 70% and < 100% by visual estimation.
6. Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).


 
 
ExclusionCriteria 
Details  1. Patients enrolled in any other drug or investigational device or in another stent trial prior 2 years, planned elective surgery or percutaneous intervention within the subsequent 3 months, staged procedure within 9 months post procedure.
2. Patient requiring treatment with a device other than PTCA prior to stent placement.
3. Target lesion exhibiting an intraluminal thrombus at any time. Lesion location that is within 5 mm of the origin of the left anterior descending or circumflex or target lesion is in a bypass graft.
4. Any co-morbid conditions impacting the scientific integrity of the trial, such as patients ability to participate in the trial or to comply with the follow-up requirements, life expectancy of less than 12 months.
5. Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
6. Patients with diagnosis of MI within 48 hours or suspected acute MI at time of enrollment.
7. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
8. Leukopenia, Neutropenia ,Thrombocytopenia, active peptic ulcer or active GI bleeding.
9. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
10. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, stainless steel or sensitivity to contrast media, which cannot be adequately pre-medicated.
11. Serum creatinine level >2.0 mg/dl within 7 days prior to index procedure.
12. Patients unable to tolerate dual anti-platelets therapy (DAPT) for 360 days post procedure.
13. Unprotected left main coronary artery disease.
14. Target vessel with any lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Major Adverse Cardiac Events (MACE)
Cardiac death
MI ( Q wave and non-Q wave)
Emergent bypass surgery
Clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 360 days.
 		 30, 180, 360 days
 
 
Secondary Outcome  
Outcome  TimePoints 
All death
Cardiac death
MI
Clinically driven TLR
Stent Thrombosis (definite/probable, ARC defined)
Acute success rates : device success, Lesion success and Procedure success.
 		 30, 180 and 360 days  
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   04/05/2016 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT APPLICABLE YET  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
›To evaluate the safety and effectiveness of the Yukon Choice PC- ELITE OR PLUS Coronary Stent System in the treatment of de novo lesions in native coronary arteries with quality standard temperature control packaging which is powered by a monitoring device. 
 
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