Coronary Artery DiseasemeriT-1NCT01507519
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
A study testing Sirolimus Eluting Coronary Stent System (Biomime) in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 1 site in India.
Trial summary
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent, highly documented drug Sirolimus \& a biocompatible, biodegradable polymer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sirolimus Eluting Coronary Stent System (Biomime)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2009to Mar 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with > 18 years of age;
- Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
- Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
- Acceptable candidate for coronary artery bypass graft (CABG) surgery;
- The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months.
- Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by visual estimation)
Show all 9Show fewer
- Target lesions ≤ 19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
- ≥ 50% and < 100% diameter stenosis;
- TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2.
Who cannot join
- Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated;
- Patient is a female with childbearing potential;
- Pre-treatment of the target lesion with any devices other than balloon angioplasty;
- Previous brachytherapy in the target vessel;
- Presence of non-target vessel lesions which require staged procedure(s) < 30 days of the index procedure;
- Prior CABG surgery to target vessel;
Show all 37Show fewer
- Previous percutaneous coronary intervention (PCI) or CABG surgery < 30 days to the index procedure date;
- Acute myocardial infarction < 3 days, with cardiac enzyme elevation including total creatine kinase (CK) > 2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
- CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
- Documented left ventricular ejection fraction < 30%;
- Renal insufficiency determined by a baseline serum creatinine > 2.0/dl;
- Thrombocytopenia with a baseline platelet count < 100,000 cells/mm3;
- Anemia with baseline hemoglobin < 10g/dL;
- Extensive peripheral vascular disease or extreme anticoagulation that precludes safe > 5 French sheath insertion;
- History of bleeding diathesis, coagulopathy, or will refuse blood transfusions;
- Patients has suffered a stroke, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within the past 6 months;
- Significant gastrointestinal or genitourinary bleed within the past 6 months;
- Patient is a recipient of a heart transplant;
- Any elective surgical procedure is planned within 12 months of the index procedure;
- Known illness or any serious clinical condition with life expectancy < 2 years;
- Participation in the active or follow-up phase of any other clinical trial within 6 months;
- Impossibility to comply with anti-platelet therapy during the study clinical follow-up;
- Any impossibility to comply with all protocol follow-ups.
- Target lesion or vessel with angiographic evidence of moderate or severe calcification;
- Presence of severe tortuosity;
- Presence of severe angulation (> 60o);
- Presence of intraluminal thrombus;
- Target lesion involving a bifurcation (side branch ≥ 2.0mm);
- Target lesion located in the left main stem;
- Aorto-ostial lesion location;
- Target lesion involving a side branch with reference diameter ≥ 2.0mm;
- Presence of a significant stenosis (> 40%) in the target vessel either proximal or distal to the target lesion that will be untreated;
- Previous placement of a stent within 10mm of the target lesion;
- Total occlusion (TIMI flow grade 0 or 1);
- Target lesion located in an arterial or vein graft;
- Target lesion due to in-stent restenosis;
- Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.
Trial locations and contacts
1 site in 1 country.
India1 site
Life Care Institute of Medical Sciences & Research
Ahmedabad, Gujarat, 380024
About this study
Official title: The First-In-Man Safety and Performance Evaluation of the Biomime Sirolimus Eluting Stent System for the Treatment of Patients With Single, De Novo, Non-Complex Coronary Lesions-The Biomime Pilot FiM Trial.
1.) Indigenously developed and designed BioMimeTM is a
- predictably safe \& efficacious 3rd generation drug eluting stent (DES)
- with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent,
- highly documented drug Sirolimus \&
- a biocompatible, biodegradable polymer
Read the detailed description
- Principal Investigator: Dr. Sameer Dani, Interventional Cardiologist, Life Care Hospital, Ahmedbad. Mobile +91 98250 38855.
- Study Title: The First-In-Man Safety and Performance Evaluation of the BiomimeTM Sirolimus-Eluting Stent System for the Treatment of Patients with Single, De novo, Non-complex Coronary Lesions - The BiomimeTM Pilot FiM Trial
- Sponsor: Meril Life Sciences Pvt. Ltd.
- Study device: BiomimeTM Sirolimus-Eluting Stent (BiomimeTM SES, Meril Life Sciences)
- Study objective: To evaluate the safety and efficacy of BiomimeTM SES.
- Study design: Phase IV, prospective study to be conducted in a single centre (Life Care Hospital, Ahmedbad)
- Study population: A total of 30 patients with stable or unstable coronary disease, or silent ischemia with documented evidence of ischemia, with angiography, and, in a pre-specified subset, intravascular ultrasound (IVUS) at 8-month follow-up.
- Participating Centre: Life Care Hospital, Ahmedabad
- QCA \& IVUS core lab: To be decided.
- Follow-up: All patients will undergo clinical follow-up at 1, 6, 12 and 24 months. All patients will undergo angiographic follow-up at 8 months. All patients will be submitted to intravascular ultrasound at 8 months.
- Primary safety endpoint: Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
- Primary efficacy endpoint:
- In-stent luminal loss assessed by quantitative coronary angiography (QCA) at 8-month follow-up
- Percentage of in-stent volume obstruction measured by IVUS at 8- month follow-up.
- Secondary endpoints:
- Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up.
- Angiographic binary restenosis at 8 months angiographic follow-up.
- Other endpoints:
- Rates of stent thrombosis (acute, sub-acute, late and very-late) up to 24 months follow-up
- In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS) by QCA at 8-month angiographic follow-up.
- In-stent acute gain by post procedure QCA.
- Late acquired incomplete stent apposition by IVUS at 8 month follow-up.
- Primary analysis: The primary endpoint will be analyzed for all subjects who had a de novo coronary lesion enrolled in this study (intention to treat)
- Conditions
- Coronary Artery Disease
- Being tested
- Sirolimus Eluting Coronary Stent System (Biomime)
- 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 Stent System (Biomime)Device
Also called Biomime Sirolimus Eluting Stent System
Coronary Artey PTCA
| Study group | Role | What they receive |
|---|---|---|
| BioMime™ | Experimental | BioMime™ DES Receives: Device: Sirolimus Eluting Coronary Stent System (Biomime) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE at 30 days clinical F/U
Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
Measured: 30 days
Secondary outcomes (1)
Angiographic Binary restenosis at 8-months F/U
- Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up.
- Angiographic binary restenosis at 8 months angiographic follow-up.
Measured: 8-months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionMar 2011
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
- Not applicable
- Intervention model
- Single group
- Model description
- BioMime™ Sirolimus-Eluting Coronary Stent System
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India
- Responsible party
- Sponsor
- Investigators
- SAMEER DANI, MD;DM(Card.), Principal investigator, Life Care Institute of Medical Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507519
- Sponsor's protocol ID
- BIOFIM/MLS/100209
- Acronym
- meriT-1
- Status last verified
- Apr 2018
- First submitted
- 6 Jan 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First-In-Man Safety and Performance Evaluation of the Biomime Sirolimus Eluting Stent System for the Treatment of Patients With Single, De Novo, Non-Complex Coronary Lesions-The Biomime Pilot FiM Trial.
- ClinicalTrials.gov ID
- NCT01507519
- Acronym / sponsor ID
- meriT-1 / BIOFIM/MLS/100209
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India
- Study start
- Apr 2009 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jan 2012 (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.
1.) Indigenously developed and designed BioMimeTM is a
- predictably safe \& efficacious 3rd generation drug eluting stent (DES)
- with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent,
- highly documented drug Sirolimus \&
- a biocompatible, biodegradable polymer
Detailed description
- Principal Investigator: Dr. Sameer Dani, Interventional Cardiologist, Life Care Hospital, Ahmedbad. Mobile +91 98250 38855.
- Study Title: The First-In-Man Safety and Performance Evaluation of the BiomimeTM Sirolimus-Eluting Stent System for the Treatment of Patients with Single, De novo, Non-complex Coronary Lesions - The BiomimeTM Pilot FiM Trial
- Sponsor: Meril Life Sciences Pvt. Ltd.
- Study device: BiomimeTM Sirolimus-Eluting Stent (BiomimeTM SES, Meril Life Sciences)
- Study objective: To evaluate the safety and efficacy of BiomimeTM SES.
- Study design: Phase IV, prospective study to be conducted in a single centre (Life Care Hospital, Ahmedbad)
- Study population: A total of 30 patients with stable or unstable coronary disease, or silent ischemia with documented evidence of ischemia, with angiography, and, in a pre-specified subset, intravascular ultrasound (IVUS) at 8-month follow-up.
- Participating Centre: Life Care Hospital, Ahmedabad
- QCA \& IVUS core lab: To be decided.
- Follow-up: All patients will undergo clinical follow-up at 1, 6, 12 and 24 months. All patients will undergo angiographic follow-up at 8 months. All patients will be submitted to intravascular ultrasound at 8 months.
- Primary safety endpoint: Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
- Primary efficacy endpoint:
- In-stent luminal loss assessed by quantitative coronary angiography (QCA) at 8-month follow-up
- Percentage of in-stent volume obstruction measured by IVUS at 8- month follow-up.
- Secondary endpoints:
- Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up.
- Angiographic binary restenosis at 8 months angiographic follow-up.
- Other endpoints:
- Rates of stent thrombosis (acute, sub-acute, late and very-late) up to 24 months follow-up
- In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS) by QCA at 8-month angiographic follow-up.
- In-stent acute gain by post procedure QCA.
- Late acquired incomplete stent apposition by IVUS at 8 month follow-up.
- Primary analysis: The primary endpoint will be analyzed for all subjects who had a de novo coronary lesion enrolled in this study (intention to treat)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BioMime™ Sirolimus-Eluting Coronary Stent System
| Arm | Type | Receives |
|---|---|---|
| BioMime™ | Experimental | Device: Sirolimus Eluting Coronary Stent System (Biomime)BioMime™ DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with > 18 years of age;
- Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
- Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
- Acceptable candidate for coronary artery bypass graft (CABG) surgery;
- The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months.
Key exclusion criteria (37 listed)
- Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated;
- Patient is a female with childbearing potential;
- Pre-treatment of the target lesion with any devices other than balloon angioplasty;
- Previous brachytherapy in the target vessel;
- Presence of non-target vessel lesions which require staged procedure(s) < 30 days of the index procedure;
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 Stent System (Biomime)Also: Biomime Sirolimus Eluting Stent SystemCoronary Artey PTCA | Device | BioMime™ |
Primary outcome
MACE at 30 days clinical F/U
Time frame: 30 days
Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
1 secondary outcome
Angiographic Binary restenosis at 8-months F/U
Time frame: 8-months post implant
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 5 Apr 2018.
- First in man studyLink provided by the sponsor.
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
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
SAMEER DANI, MD;DM(Card.) principal investigator
Life Care Institute of Medical Sciences & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus Eluting Coronary Stent System (Biomime) in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 1 site 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 9 inclusion and 37 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 5 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 1 site 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?
MACE at 30 days clinical F/U (time frame: 30 days). 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 5 Apr 2018.