Angina PectorisMorpheusNCT02901353
A Prospective, Single-arm, Multi-centre, Observational, Real World Registry
An observational study of Angina Pectoris, run by Meril Life Sciences Pvt. Ltd. at 5 sites in 4 countries.
Trial summary
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Sirolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 2 Feb 2017to 1 Dec 2022
- How long will I take part?
- 24 Months
- 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 utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Who may be able to join
- The patient must be at least 18 years of age.
- Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of ≤56mm.
- The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -
Who cannot join
- Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigational study.
- -
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Hungary2 sites, 2 recruiting
- Recruiting
University of Semmelweis
Budapest, Europe, 1085
Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc, Merkely.Bela@kardio.sote.hu
- Recruiting
University of Debrecen
Debrecen, Europe, 4032
Dr. Szűk Tibor, Ph.D, MD, tszuk01@gmail.com
Jordan1 site, 1 recruiting
- Recruiting
Jordan Hospital
Amman
Dr. Imad A Haddad, MD, alhaddad63@gmail.com
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Selangor, 59100
Dr. Ramesh Singh, MBBS, MRCP, ramesh@ummc.edu.my
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, Germany, 3435CM
Dr. P. Agostoni
About this study
Official title: A Prospective, Single-arm, Multi-centre, Observational, Real World Registry to Evaluate Safety and Performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for Very Long Coronary Lesions.
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Read the detailed description
Title:
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Short Title:
Morpheus - Global Registry Sponsor: Meril Life Sciences Pvt. Ltd
Device Used:BioMime™ Morph Sirolimus Eluting Coronary Stent System
Study population:
The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Enrolment:Minimum 400 patients will be enrolled
Clinical Sites:Minimum 15 sites
Objectives:Purpose of this Registry is to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Study Design:This is a prospective, single-arm, multi-centre, observational, real world registry. All patients will be followed for up to 24 months.
Primary Outcome Measures:Freedom of target lesion failure (TLF) at 6 month and up to 24 month TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization.
Secondary Outcome Measures:
- MACE at 1, 6, 12 and 24 month Defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR .
- Target vessel failure at 1, 6, 12 and 24 month Defined as cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.
- Academic Research Consortium (ARC) defined stent thrombosis at 1, 6, 12 and 24 months.
Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.
Other Outcome Measures:
- Procedure Success: It is defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MACE prior to hospital discharge (for subjects with more than one lesion stented, the worse case is counted)
- Device Success:
It is defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device
- Conditions
- Angina Pectoris
- Being tested
- Sirolimus Eluting Coronary Stent System
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Eluting Coronary Stent SystemDevice
Patient with Angina Pectoris will be enrolled for the intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of target lesion failure
composite of cardiac death, myocardial infarction and target lesion revascularization.
Measured: TLF at 6 month
Freedom of target lesion failure
composite of cardiac death, myocardial infarction and target lesion revascularization.
Measured: TLF upto 24 months
Secondary outcomes (3)
MACE
composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR.
Measured: 1, 6, 12 and 24 month
Target vessel failure
cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.
Measured: 1, 6, 12 and 24 month
Academic Research Consortium (ARC) defined stent thrombosis
Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.
Measured: 1, 6, 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start2 Feb 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc, Principal investigator, University of SemmelweisDr. Szűk Tibor, Ph.D, MD, Principal investigator, University of DebrecenDr. P. Agostoni, Ph.D, MD, Principal investigator, St. Antonius NieuwegeinDr. Imad A Haddad, MD, Principal investigator, Jordan HospitalDr. Ramesh Singh, MBBS, MRCP, Principal investigator, University Malaya Medical Centre (UMMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901353
- Sponsor's protocol ID
- BIO/MOR-I
- Acronym
- Morpheus
- Status last verified
- Feb 2020
- First submitted
- 11 Aug 2016
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-centre, Observational, Real World Registry to Evaluate Safety and Performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for Very Long Coronary Lesions.
- ClinicalTrials.gov ID
- NCT02901353
- Acronym / sponsor ID
- Morpheus / BIO/MOR-I
- Conditions
- Angina Pectoris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Sep 2016 (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.
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Detailed description
Title:
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Short Title:
Morpheus - Global Registry Sponsor: Meril Life Sciences Pvt. Ltd
Device Used:BioMime™ Morph Sirolimus Eluting Coronary Stent System
Study population:
The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Enrolment:Minimum 400 patients will be enrolled
Clinical Sites:Minimum 15 sites
Objectives:Purpose of this Registry is to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Study Design:This is a prospective, single-arm, multi-centre, observational, real world registry. All patients will be followed for up to 24 months.
Primary Outcome Measures:Freedom of target lesion failure (TLF) at 6 month and up to 24 month TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization.
Secondary Outcome Measures:
- MACE at 1, 6, 12 and 24 month Defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR .
- Target vessel failure at 1, 6, 12 and 24 month Defined as cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.
- Academic Research Consortium (ARC) defined stent thrombosis at 1, 6, 12 and 24 months.
Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.
Other Outcome Measures:
- Procedure Success: It is defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MACE prior to hospital discharge (for subjects with more than one lesion stented, the worse case is counted)
- Device Success:
It is defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.
Key inclusion criteria (3 listed)
- The patient must be at least 18 years of age.
- Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of ≤56mm.
- The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -
Key exclusion criteria (4 listed)
- Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigational study.
- -
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 SystemPatient with Angina Pectoris will be enrolled for the intervention | Device | – |
Primary outcome
Freedom of target lesion failure
Time frame: TLF at 6 month
composite of cardiac death, myocardial infarction and target lesion revascularization.
Freedom of target lesion failure
Time frame: TLF upto 24 months
composite of cardiac death, myocardial infarction and target lesion revascularization.
3 secondary outcomes
MACE
Time frame: 1, 6, 12 and 24 month
Target vessel failure
Time frame: 1, 6, 12 and 24 month
Academic Research Consortium (ARC) defined stent thrombosis
Time frame: 1, 6, 12 and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc principal investigator
University of Semmelweis
Dr. Szűk Tibor, Ph.D, MD principal investigator
University of Debrecen
Dr. P. Agostoni, Ph.D, MD principal investigator
St. Antonius Nieuwegein
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris, run by Meril Life Sciences Pvt. Ltd. at 5 sites in 4 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 3 inclusion and 4 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 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hungary, Jordan, Malaysia, Netherlands. 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?
Contact Ashok Thakkar, Ph.D (+91 9879443584, ashok.thakkar@merillife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of target lesion failure (time frame: TLF at 6 month). The study lists 2 primary outcomes in all. 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 21 Feb 2020.