Coronary Artery DiseasemeriT-VNCT02112981
BioMime Vs. Xience Randomised Control Clinical Study
A study testing Sirolimus Eluting Coronary Stent and Everolimus-eluting Coronary stent in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 15 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sirolimus Eluting Coronary Stent and Everolimus-eluting Coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 5 Nov 2014to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
Brazil3 sites
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909
Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
São Paulo, 05403-000
Instituto do Coracao do Triangulo Mineiro
Uberlândia, 38411-186
Netherlands3 sites
Albert Schweitzer
Dordrecht, South Holland, 3300
Catharina Cardiac Centre
Eindhoven, North Brabant, 5623
Isala Hospital
Zwolle, 8025
Czechia2 sites
Fn Brno, Jihlavska 20
Brno, 602 00
St. Anne's Univeristy Hospital Brno
Brno-střed, Brno, 656 91
United Kingdom2 sites
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Manchester Heart Centre
Manchester, England, M13 9WL.
Latvia1 site
University of Latvia, Research Institute of Cardiology
Riga, Europe, LV1002
About this 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.
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Sirolimus Eluting Coronary Stent, Everolimus-eluting Coronary stent
- Keywords
- Coronary Arteriosclerosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Eluting Coronary StentDevice
Also called BioMime Sirolimus Eluting 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 stentDevice
Also called XIENCE family of Everolimus-eluting 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).
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus Eluting Coronary Stent | Experimental | BioMime Sirolimus Eluting Stent of Meril Life Sciences Receives: Device: Sirolimus Eluting Coronary Stent |
| Everolimus-eluting Coronary stent | Active comparator | XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc. Receives: Device: Everolimus-eluting Coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (4)
Frequency of Binary restenosis by Angiography
Binary Restenosis (DS ≥50%)
Measured: 9 months
Minimum Lumen Diameter by Angiography
MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure
Measured: 9 months
In-segment Late Lumen Loss at 9 months
In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins.
Measured: 9 months
Clinical Evaluation
Major Adverse Cardiac Events (MACE)
Measured: 1, 5, 9, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start5 Nov 2014
- Primary completion6 Sep 2017
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alexandre Abizaid, Ph.D, MD, Principal investigator, Instituto Dante Pazzanese de CardiologiaDr. Roberto V Botelho, MD, Principal investigator, Instituto do Coracao do Triangulo MineiroDr. Pedro Lemos, MD, Principal investigator, Instituto do Coracao - HCFMUSP Centro de Pesquisa ClinicaDr. Expedito Ribeiro, MD, Principal investigator, Instituto do Coracao - HCFMUSP Centro de Pesquisa ClinicaDr. Elvin Kedhi, Ph.D, MBBS, Principal investigator, IsalaDr. Pim Tonino, MD, Principal investigator, Catharina Cardiac CentreDr. Floris Kauer, MD, Principal investigator, Albert SchweitzerDr. Luc Janssen, MD, Principal investigator, Imelda Ziekenhuis Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112981
- Sponsor's protocol ID
- BioM/RCT/12/03
- Other IDs
- 2013-005353-67
- Acronym
- meriT-V
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02112981
- Acronym / sponsor ID
- meriT-V / BioM/RCT/12/03
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
| Arm | Type | Receives |
|---|---|---|
| Sirolimus Eluting Coronary Stent | Experimental | Device: Sirolimus Eluting Coronary StentBioMime Sirolimus Eluting Stent of Meril Life Sciences |
| Everolimus-eluting Coronary stent | Active comparator | Device: Everolimus-eluting Coronary stentXIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus Eluting Coronary StentAlso: BioMime Sirolimus Eluting StentBioMimeTM 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. | Device | Sirolimus Eluting Coronary Stent |
| Everolimus-eluting Coronary stentAlso: XIENCE family of Everolimus-eluting stentXience 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). | Device | Everolimus-eluting Coronary stent |
Primary outcome
To assess in-stent Late Lumen Loss
Time frame: 9 months
The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies.
4 secondary outcomes
Frequency of Binary restenosis by Angiography
Time frame: 9 months
Minimum Lumen Diameter by Angiography
Time frame: 9 months
In-segment Late Lumen Loss at 9 months
Time frame: 9 months
Clinical Evaluation
Time frame: 1, 5, 9, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Alexandre Abizaid, Ph.D, MD principal investigator
Instituto Dante Pazzanese de Cardiologia
Dr. Roberto V Botelho, MD principal investigator
Instituto do Coracao do Triangulo Mineiro
Dr. Pedro Lemos, MD principal investigator
Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus Eluting Coronary Stent and Everolimus-eluting Coronary stent in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Brazil, Netherlands, Czechia, United Kingdom, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess in-stent Late Lumen Loss (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.