Clinical trial NCT02112981: BioMime Vs. Xience Randomised Control Clinical Study
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Arteriosclerosis
Lead sponsor: Meril Life Sciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess in-stent Late Lumen Loss
timeFrame: 9 months
Secondary outcomes:
measure: Frequency of Binary restenosis by Angiography
timeFrame: 9 months
measure: Minimum Lumen Diameter by Angiography
timeFrame: 9 months
measure: In-segment Late Lumen Loss at 9 months
timeFrame: 9 months
measure: Clinical Evaluation
timeFrame: 1, 5, 9, 12 and 24 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis Cardiology
state: Western Europe
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
city: Uberlândia
country: Brazil
facility: Instituto do Coracao do Triangulo Mineiro
city: Brno-střed
country: Czechia
facility: St. Anne's Univeristy Hospital Brno
state: Brno
city: Brno
country: Czechia
facility: Fn Brno, Jihlavska 20
city: Riga
country: Latvia
facility: University of Latvia, Research Institute of Cardiology
state: Europe
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Cardiology
city: Eindhoven
country: Netherlands
facility: Catharina Cardiac Centre
state: North Brabant
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer
state: South Holland
city: Zwolle
country: Netherlands
facility: Isala Hospital
city: Tychy
country: Poland
facility: American Heart Institure S.A.
state: Silesia
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: England
city: Manchester
country: United Kingdom
facility: Manchester Heart Centre
state: England
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Dr. Alexandre Abizaid, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coracao do Triangulo Mineiro
name: Dr. Roberto V Botelho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
name: Dr. Pedro Lemos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
name: Dr. Expedito Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala
name: Dr. Elvin Kedhi, Ph.D, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Cardiac Centre
name: Dr. Pim Tonino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Schweitzer
name: Dr. Floris Kauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imelda Ziekenhuis Cardiology
name: Dr. Luc Janssen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Heart Centre
name: Dr. Farzin F Ordoubadi, B.Sc, MB BCHIR, MRCP, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Bournemouth Hospital
name: Dr. Suneel Talwar, MBBS, MRCP, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic
name: Dr. Monica Masotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Latvia, Research Institute of Cardiology
name: Dr. Andrejs Erglis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic of Cardiology
name: Prof. Sasko Kedev, Ph.D, MD, FESC, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Anne's Univeristy Hospital Brno
name: Dr. Ota Hlinomaz, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fn Brno, Jihlavska 20
name: Dr. Petr kala, Ph.D, MD, FESC, FSCAI
role: PRINCIPAL_INVESTIGATOR
affiliation: American Heart Institure S.A.
name: Dr. Krzysztof Milewski, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
References: