BioMime Vs. Xience Randomised Control Clinical Study

Coronary Artery Disease Clinical Trial

— meriT-V  

Official title:

A Prospective, Active Control Open Label, Multicentre Randomized Clinical Trial for Comparison Between BioMime Sirolimus Eluting Stent of Meril Life Sciences and Xience Everolimus Eluting Stent of Abbott Vascular Inc. to Evaluate Efficacy and Safety in Coronary Artery Disease.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02112981
• Other study ID #: BioM/RCT/12/03
• Secondary ID: 2013-005353-67
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 5, 2014
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2018
• Source: Meril Life Sciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.

Description:

This study is conducted to evaluate the multicenter investigation comparing the BioMime Sirolimus Drug Eluting stent with XIENCE family of (Abbott Vascular, Santa Clara, California, USA) in the treatment of patients with coronary artery disease. Considering that the randomized studies provide a better comparability and a real efficacy and safety data of the devices. Subjects will be randomized 2:1 with surrogate endpoints and clinical evaluation.

Subject included in study are eligible to meet the inclusion and exclusion criteria of the study protocol .The informed consent process will be performed before the subject underwent for the Procedure. Subject will be treated with treatment allocated by the process of Randomization. The study follow up will be Seattle angina score evaluation up to 2 years after the procedure of angioplasty along with the Hospital or telephonic follow up at 1 Month 5month ,1 and 2 years and angiographic follow up at 9 Month.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: December 1, 2019
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be =18 years of age.

• 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

• The patient has a planned intervention of up to two de-novo native lesions

• Target lesion reference diameter = 2.5 mm and = 3.5 mm in diameter (visually estimated)

• The target lesion length is less than or equal to 46 mm (visually estimated)

• Patient willing to provide written informed consent.

• If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal.

• The patient and the patient's physician agree to the follow-up visits including a 9 month angiographic follow-up.

Exclusion Criteria:

• 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.

• The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus.

• There is an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.

• Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion.

• Lesion with a significant side branch (branch diameter >2 mm) that would be covered by stenting

• Total occlusion or TIMI 0 coronary flow in the target vessel.

• Left Main coronary artery disease (stenosis >50%)

• The proximal target vessel or target lesion is severely calcified by visual assessment.

• Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.

• The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months

• The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl or 180 µmol/l.

• The target lesion, or the target vessel proximal to the target lesion contains thrombus

• Documented left ventricular ejection fraction of =30%

• The patient is a recipient of a heart transplant

• The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme angulations of the vessel at accesslocation (< 45 degrees)

• 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)

• The patient is simultaneously participating in another investigational device or drug study

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Sirolimus Eluting Coronary Stent
BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers.
• Everolimus-eluting Coronary stent
Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient).

Locations

Country	Name	City	State
Belgium	Imelda Ziekenhuis Cardiology	Bonheiden	Western Europe
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Brazil	Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica	São Paulo
Brazil	Instituto do Coracao do Triangulo Mineiro	Uberlândia
Czechia	Fn Brno, Jihlavska 20	Brno
Czechia	St. Anne's Univeristy Hospital Brno	Brno-stred	Brno
Latvia	University of Latvia, Research Institute of Cardiology	Riga	Europe
Macedonia, The Former Yugoslav Republic of	University Clinic of Cardiology	Skopje
Netherlands	Albert Schweitzer	Dordrecht	South Holland
Netherlands	Catharina Cardiac Centre	Eindhoven	North Brabant
Netherlands	Isala Hospital	Zwolle
Poland	American Heart Institure S.A.	Tychy	Silesia
Spain	Hospital Clinic	Barcelona	Catalonia
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Manchester Heart Centre	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
Meril Life Sciences Pvt. Ltd.

Countries where clinical trial is conducted

Belgium,  Brazil,  Czechia,  Latvia,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess in-stent Late Lumen Loss	The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies.	9 months
Secondary	Frequency of Binary restenosis by Angiography	Binary Restenosis (DS =50%)	9 months
Secondary	Minimum Lumen Diameter by Angiography	MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure	9 months
Secondary	In-segment Late Lumen Loss at 9 months	In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins.	9 months
Secondary	Clinical Evaluation	Major Adverse Cardiac Events (MACE)	1, 5, 9, 12 and 24 months