CTRI/2017/01/007638 [Registered on: 06/01/2017] Trial Registered Prospectively
Last Modified On:
13/09/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Medical Device
Study Design
Single Arm Study
Public Title of Study
To evaluate safety and performance of CREDENCEâ„¢ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with de novo native peripheral artery lesions.
Scientific Title of Study
CREDENCE™ BRS – 1: A prospective, open label and multicentric clinical study to evaluate safety and performance of CREDENCE™ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with de novo native peripheral artery lesions.
Trial Acronym
Credence BRS
Secondary IDs if Any
Secondary ID
Identifier
CREDENCE™ BRS – 1/Version 1.0.0_20 April 2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vimal Someshwar
Designation
Chief Investigator
Affiliation
Kokilaben Dhirubhai Ambani Hospital & Medical Research
Department of Cardiology, Wardha-442004, Maharashtra, India Wardha MAHARASHTRA
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 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 MAHARASHTRA
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 ANDHRA PRADESH
9848053220
pcgupta10@hotmail.com
Dr Sanjay Tyagi
G B Pant Hospital
Department of Cardiology, G B Pant Institute, 1, Jawaharlal Nehru Marg, New Delhi, India New Delhi DELHI
9891356668
drsanjaytyagi@yahoo.com
Dr Sitaram Barath
Geetanjali Medical College and Hospital
Department of Neuro and Vascular Interventional Radiology , Manwakhera, NH-8 Bypass, Near Eklingpura Chouraha, Udaipur, Rajasthan 313002, India Udaipur RAJASTHAN
9629552980
Barath.sitaram@gmail.com
Dr Tarun Madan
HCG Medi-Surge Hospital
Department of Cardiology, Mithakhali Six Road, Ellis Bridge, Ahmedabad-380006, Gujarat, India Ahmadabad GUJARAT
9824743624
drtarunmadan@yahoo.co.in
Dr Gireesh Warawdekar
Holy Family Hospital
Department of Cardiology, Junction of Hill Road and St Andrew’s Road, Hill Rd, Bandra West, Mumbai-400050, Maharashtra, India Mumbai MAHARASHTRA
9820053028
Gireesh.w@gmail.com
Dr Vimal Ravindra Someshwar
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
2nd floor, Cath Lab, Medical Research Department
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Four Bungalows | Andheri – West
Mumbai – 400 053
Mumbai MAHARASHTRA
9820064685
someshwarrupal@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 400022, Maharashtra, India. Mumbai MAHARASHTRA
9869335336
dhruvrays@hotmail.com
Dr Sanjay Desai
M S Ramaiah Hospital
Department of Cardiology, M. S. Ramaiah Memorial Hospital, New BEL Road, M.S. Ramaiah Nagar, MSRIT Post, Bangalore 560054, India Bangalore KARNATAKA
9845290575
scdesai@hotmail.com
Dr B B Chanana
Maharaja Agrasen hospital
Department of Cardiology, Maharaja Agrasen hospital, West Punjabi Bagh, New Delhi 110026, India New Delhi 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 DELHI
9810205525
Kumud.rai@maxhealthcare.com
Dr Kamerkar Dhanesh
Ruby Hall Clinic
Department of Cardiology, Ruby Hall Clinic, 40, Sassoon Road, Pune 411001, Maharashtra, India Pune MAHARASHTRA
9822041808
dhaneshkamerkar@gmail.com
Dr Varinder Singh Bedi
Sir Ganga Ram Hospital
Department of Cardiology, Rajinder Nagar, New Delhi 110060, Delhi, India New Delhi DELHI
Credenceâ„¢ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System
Credenceâ„¢ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Subject is ≥18 years of age.
2. Subject has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
3. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).
a. For subjects with bilateral lesions, the higher Rutherford-Becker clinical category limb will be considered the target
b. If both limbs are of the same Rutherford Becker clinical category, the target extremity will be selected based on investigator discretion.
4. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
5. Female subject of childbearing potential must have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.
6. Subject has life expectancy > 12 months.
7. Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).
8. Subject must agree not to participate in any other clinical investigation for a period of 5 years following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
Angiographic Inclusion Criteria:
1. Reference vessel diameter (RVD) 2.0-10.0 mm measured by an objective measurement such as online Quantitative Vessel Analysis (QVA).
2. Target lesion is ≥ 50% DS.
3. Target lesion length ≤ 70 mm.
4. Patent inflow artery free from significant lesion (≥ 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion).
5. Patent popliteal artery free from significant lesion (≥ 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography.
ExclusionCriteria
Details
1. Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176μmol/L).
2. Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
3. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL.
4. Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to sirolimus (i.e. tacrolimus, everolimus, zotarolimus) or other macrolides.
5. Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
6. Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
7. Subject is unable to walk.
8. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
9. Subject has received, or is on the waiting list for, an organ transplant.
10. Subject is on chronic haemodialysis.
11. Subject has uncontrolled diabetes mellitus (DM) (HbA1c ≥ 7.0%).
12. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
13. Subject has unstable angina defined as rest angina with ECG changes.
14. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
15. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
16. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 12 months.
17. Subject is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
18. Subject is unable to understand or unwilling to cooperate with study procedures.
19. Subject requires general anesthesia for the procedure.
20. Subject has ischemic or neuropathic ulcers on either foot.
21. Subject has prior minor or major amputation of either lower extremity.
22. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
23.Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits for from a prior stroke that limits the subjects ability to walk.
Angiographic Exclusion Criteria:
1. Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).
2. Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.
3. Acute ischemia of the target extremity.
4. Target extremity has been previously treated with any of the following:
•Surgical by pass or
•Endarterectomy
5. Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.
6. Total occlusion (100 % DS) of the ipsilateral inflow artery.
7. Angiographic evidence of thrombus in target vessel.
8. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.).
9. Target lesion is within or adjacent to an aneurysm.
10. Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.
11. Target lesion has moderate-to-severe calcification with either of the following characteristics:
•Circumferential orientation.
•Thickness > 2 mm in either radial or longitudinal direction.
12. Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
long-term patency outcomes include drug-eluting stents (DES) and drug-coated balloons (DCB) that deliver antirestenotic agents to the vessel wall and self-expanding covered stents or stent-grafts that prevent neointimal in growth at the site of treatment
1 Month,6 Months,12 Months, 2 years,3 years,4 years and 5 years
Secondary Outcome
Outcome
TimePoints
1. Technical success of the stenting procedure.Technical Success is defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually
2. Procedural success of the stenting procedure. Procedural Success is defined as technical success with no MAEs noted within 24 hours of the index procedure
3. Clinically-driven TLR Rate.
1 Month,6 Months,12 Months, 2 years,3 years,4 years and 5 years
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "30" Final Enrollment numbers achieved (India)="30"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Peripheral arterial disease (PAD) is the systemic arteriosclerosis symptomatically affecting between 3% and 7% of the population and up to one in five patients older than 75 years of age. Mortality in patients with intermittent claudication (IC) is up to four times that in the nonclaudicants. Approximately 55% of claudicants may die from heart disease, 10% from a stroke, and 10% from abdominal vascular pathology. Percutaneous intervention (angioplasty and/or stenting) is the suggested treatment of choice in patients with intermittent claudication (IC) or critical limb ischemia (CLI).
Despite the high initial technical success rate of femoral percutaneous transluminal angioplasty (PTA), elastic recoil of the vessel wall, extensive intimal dissection, restenosis and due to intimal hyperplasia remains the major limitations of this technique. Although the use of metallic stents has the ability to overcome acute limitations such as elastic recoil and dissection, long-term outcomes may be compromised by the development of neointimal hyperplasia and late restenosis. Several studies reported that excluding CLI, long-term outcomes of primary stent implantation and balloon angioplasty were similar.
Then the Self- Expanding Stents were evaluated by Stent Engineering. Self-expanding nitinol stents again improved endovascular treatment of femoropopliteal disease. Old generation balloon-expandable metal stents are no longer used in the femoropopliteal segment as they are susceptible to external compression and longitudinal axis deformation related to restenosis. New generation, self-expanding stents, manufactured from a nickel-titanium alloy (nitinol), demonstrate elastic and thermal memory properties suitable for the infrainguinal arterial bed. Nitinol stents conform their superior resistance to torsion, flexion, extension, contraction, and compression compared to stainless steel. Radial expansion of nitinol stents occurs with in situ intra-arterial stent heating and 10–20-fold increase in “spring-like†behavior of nitinol was achieved compared with stainless steel alloys, nitinol stents achieve the predefined nominal diameter once deployed without significant foreshortening. Overlap of nitinol stents must be minimized or ideally avoided as it relates to increased risk of fracture and site-specific restenosis. Suboptimal nitinol stent expansion was related to heavily calcified eccentric or ring-like concentric plaques. Finally, self-expandable stent technology demonstrates specific high resistance to deformation.