Coronary Artery DiseasemeriT-2NCT02406326

An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

An observational study of Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10 patients per centre involving approximately 25 centres). Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 months \& 12 months. All patients will have a repeat angiography at 8 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
How many people: 250 participants
Where: 11 sitesIndia
Study dates: 27 Aug 2009to 27 Dec 2016
How long will I take part?: 5 Years
Phase: Observational
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

Study population: The study population will consist of 250 patients with an obstructive coronary artery disease with few exclusion criteria.

Who may be able to join

The patient must be ≥18 years of age;
Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia;
TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ;
C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;
Target lesion stenosis is >50% and <100% ;

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Target lesions are de novo;
Target lesions ≤ 35mm in length (by visual estimation) that can be treated (covered) by one single study stent (13 to 40mm in length)
Target lesion located in a major epicardial coronary vessel with reference of ≥ 2.5 - ≤ 3.5mm in diameter (by visual estimation)
Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)
The patient and/or his legal representative has been informed of the nature of the study and agrees to its provisions and has provided a written informed consent.

Who cannot join

General exclusion criteria:
Women of childbearing potential;
Impaired renal function (creatinine > 2.0 mg/dl or 180 μmol/l);
Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of Hepatitis;
Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
History of CVA or TIA within the last 3 months

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Patient with a concomitant disease having a life expectancy of less than 12 months;
Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavix®), Heparin, Cobalt Chromium/Nickel, contrast media;
Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding;
Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia
Patients with Cardiogenic Shock.
Angiographic Exclusion criteria:
Left main coronary artery disease with ≥ 50% stenosis,
Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other adjunctive interventions such as Angiojet, Exciser, Thrombolysis, etc.),
Left Ventricular Ejection Fraction ≤30 %,
Saphenous Vein Graft Interventions, (S.V.G's)
Patients presenting with an ongoing Acute Myocardial Infarction (AMI),
Patients having undergone a PCI within 48 hours of an AMI episode.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

India11 sites

Columbia Asia Hospitals
Bangalore, Karnataka, 560055
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, 560069
Narayana Hrudayalaya Institute of Medical Sciences
Bangalore, Karnataka, 560099
Advance Cardiac Centre
Chandigarh, Punjab, 160012
Madras Medical Mission
Chennai, Tamil Nadu, 600037
Apollo Group of Hospitals
Chennai, Tamil Nadu, 600081
Kovai Medical Centre and Hospitals Ltd
Coimbatore, Tamil Nadu, 641014
Hero DMC Heart Institute
Ludhiana, Punjab, 141001
Fortis/Wockhardt Hospital
Mumbai, Maharashtra, 400011
Fortis Escorts Heart Institute & Research Centre
New Delhi, National Capital Territory of Delhi, 110025
Poona Hopsital & Research Centre
Pune, Maharshtra, 411030

Other trials in India

About this study

Official title: A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

Read the detailed description

This is a multi centre, prospective observational study. 250 patients will be enrolled in the study. 10 patients per centre involving approximately 25 centres. All the patients will be followed for twelve months post-procedure. All patients will have a repeat angiography assessment at 8 months. An additional clinical follow-up will be maintained for years 3 \& 5 post-implant.

Approximately 250 patients with obstructive coronary artery disease with a vessel size between ≥2.5 to ≤3.5 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the Sirolimus Eluting Stent.

It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.

Conditions: Coronary Artery Disease
Medical subject headings: Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Cardiac Events (MACE) days
composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or Clinically driven TLR (repeat PCI or CABG) and measured percentage wise
Measured: 30 days

Secondary outcomes (4)

Major Adverse Cardiac Events (MACE)
Major adverse cardiac events is defined as the aggregate of cardiac death, myocardial infarction (MI) attributed to target vessel, and any target lesion revascularization (TLR)
Measured: Until 12 months
Device related SAEs
Serious Adverse Events
Measured: Until 12 months
Angioghraphic stent thrombosis
Acute (In hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months)
Measured: After 30 days until 12 months
Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization
Quantitative Coronary Angiography derived vessel parameters In stent and 5 mm proximal and 5 mm distal from the edge of the stent (In-segment), Acute Gain (mm), Mild (%), Late loss (mm) and Binary Restenosis (%) rate, In stent MLD pre, post and 8 months angiographic follow up.
Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 200927 Dec 2016

First posted2 Apr 2015 (estimated)
Study start27 Aug 2009
Primary completion27 Dec 2016
Study completion27 Dec 2016

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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 250 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02406326
Sponsor's protocol ID: BIO1TR/MLS/100209
Acronym: meriT-2
Status last verified: Apr 2018
First submitted: 30 Mar 2015
Last updated: 11 Apr 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.
ClinicalTrials.gov ID: NCT02406326
Acronym / sponsor ID: meriT-2 / BIO1TR/MLS/100209
Conditions: Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
Study start: 27 Aug 2009 (actual)
Primary completion: 27 Dec 2016 (actual)
Study completion: 27 Dec 2016 (actual)
First posted: 2 Apr 2015 (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.

Detailed description

It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of 250 patients with an obstructive coronary artery disease with few exclusion criteria.

Key inclusion criteria (11 listed)

The patient must be ≥18 years of age;
Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia;
TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ;
C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;

Key exclusion criteria (19 listed)

Women of childbearing potential;
Impaired renal function (creatinine > 2.0 mg/dl or 180 μmol/l);
Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of Hepatitis;
Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
History of CVA or TIA within the last 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Major Adverse Cardiac Events (MACE) days
Time frame: 30 days
composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or Clinically driven TLR (repeat PCI or CABG) and measured percentage wise

4 secondary outcomes

Major Adverse Cardiac Events (MACE)
Time frame: Until 12 months
Device related SAEs
Time frame: Until 12 months
Angioghraphic stent thrombosis
Time frame: After 30 days until 12 months
Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization
Time frame: At 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Study results at 12 month follow upLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Coronary Artery Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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RecruitingObservational study
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Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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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. Ashok Seth, FRCP, FACC,FMRCP, MBBS principal investigator

Fortis Escorts Heart Institute & Research Centre

Dr. Ajit Mullasari, DNB, DM, MD, MBBS principal investigator

Madras Medical Mission

Dr. Rohit M Kumar, DM, MD, MBBS principal investigator

Advance Cardiac Centre

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 11 sites in India.

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 11 inclusion and 19 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: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major Adverse Cardiac Events (MACE) days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406326.

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 11 Apr 2018.