Prospective clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience Everolimus stent by random assignment for treatment of coronary artery disease at multinational centres

• Register: ISRCTN
• Last refreshed on: 2 September 2019
• Main ID: ISRCTN06697555
• Date of registration: 16/04/2014
• Prospective Registration: Yes
• Primary sponsor: Meril Life Sciences Pvt. Ltd. (India)
• Public title: Prospective clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience Everolimus stent by random assignment for treatment of coronary artery disease at multinational centres
• Scientific title: A prospective, active control open label, multicentre randomized clinical trial for comparison between BioMime Sirolimus Eluting Stent of Meril Life Sciences Pvt.Ltd. and Xience Xpedition Everolimus Eluting stent of Abbott Vascular Inc. to evaluate efficacy and safety in Coronary Artery Disease
• Date of first enrolment: 20/04/2014
• Target sample size: 258
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN06697555
• Study type: Interventional
• Study design: Two year multi centre open label randomized parallel group active control comparator clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Belgium, Brazil, Italy, Latvia, Netherlands, Spain, Switzerland, United Kingdom

Contacts

• Name: Ashish Indani

Key inclusion & exclusion criteria

Inclusion criteria:
1. The patient must be =18 years of age.
2. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
3. The patient has a planned intervention of up to two de-novo native lesions
4. Target lesion reference diameter = 2.5 mm and = 3.5 mm in diameter (visually estimated)
5.The target lesion length is less than or equal to 46 mm (visually estimated)
6. Patient willing to provide written informed consent.
7. If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal.
8. The patient and the patient?s physician agree to the follow-up visits including a 9 month angiographic follow-up.

Exclusion criteria:
1. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit.
2. The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus.
3. There is an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
4. Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion.
5. Lesion with a significant side branch (branch diameter >2 mm) that would be covered by stenting
6. Total occlusion or TIMI 0 coronary flow in the target vessel.
7. Left Main coronary artery disease (stenosis >50%)
8. The proximal target vessel or target lesion is severely calcified by visual assessment.
9. Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
10. The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
11. The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months
12. The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl or 180 µmol/l.
13. The target lesion, or the target vessel proximal to the target lesion contains thrombus
14. Documented left ventricular ejection fraction of =30%
15. The patient is a recipient of a heart transplant
16. The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme angulations of the vessel at accesslocation (< 45 degrees)
17. The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year)
18. The patient is simultaneously participating in another investigational device or drug study.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

De novo native coronary artery lesions
Circulatory System

Intervention(s)

There will be overall 258 subjects (86 in Control arm and 172 in Study arm) after proper screening and obtaining informed consent form. The randomization will be IWRS based 2:1 randomization of the patients. There will be no stratification factors applied to the population. All the subjects will undergo interventional stent Implantation (Angioplasty) as a part of their treatment, it is not added intervention for protocol. However, the stent choice will be by IWRS-based randomization.

Patients will be followed clinically for a period of 2 years. All patients will undergo angiographic follow-up at 9.5 months. All subjects in the study will undergo the clinical follow-up at 30 ± 7 days, 5 months ± 7 days, 12 months ± 7 days and 24 months ± 7 days. QCA assessment will be performed both at baseline and at 9 months after enrolment.

Primary Outcome(s)

To assess in-stent Late Lumen Loss at 9 months for both treatment strategies

Secondary Outcome(s)

Angiographic endpoints:
1. Binary Restenosis (DS =50%) at 9 months
2. MLD and %DS post procedure at 9 months
3. In-segment Late Lumen Loss at 9 months
All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.

Clinical endpoints:
1. Acute success (Device and Procedural success)
2. Device-oriented Composite Endpoints at 1, 5, 9, 12 and 24 months and its individual components. (Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization)
3. Non clinically-indicated Target Lesion revascularization (TLR) at 1, 5, 9, 12 and 24 months
4. Clinically-indicated and non clinically-indicated Target Vessel revascularization (TVR) at 1, 5, 9, 12 and 24 months

Secondary ID(s)

2013-005353-67

BioM/RCT/12/03

NCT02112981

Source(s) of Monetary Support

Meril Life Sciences Pvt. Ltd. (India)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 20/10/2016