Coronary Artery DiseaseMorph RCT-1NCT03721614
Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.
A study testing BioMime™ Morph - Sirolimus Eluting Coronary Stent System and Xience family Everolimus Coronary Stent Systems in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
Trial summary
A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in… 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?
- BioMime™ Morph - Sirolimus Eluting Coronary Stent System and Xience family Everolimus Coronary Stent Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 22 Jun 2022
- 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
- Patient must be at least ≥18 years of age.
- Significant de novo native coronary artery stenosis as part of Ischemic Heart Disease with lesion length of ≥26 mm and ≤56 mm (irrespective of number of lesions) with reference vessel diameter of (Proximal to Distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.50 - 3.00 mm.
- Patient with lesion(s), with a visually estimated stenosis of ≥50% and <100% with a TIMI flow of ≥1.
- Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. This includes clinical trials of medication and invasive procedures, questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
- Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal.
- Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable Regulatory Authorities.
- Patient must agree to undergo all clinical investigations and follow up visits as per protocol.
Who cannot join
- Patients with known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, anti-platelet medication specified for use in the study, everolimus and sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure(Pregnancy should be confirmed based on positive urine pregnancy test as part of screening procedure)
- An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT.
- Patient has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Patient has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK-MB/Troponin T/Troponin I values have not returned to within normal limits at the time of procedure.
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
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- Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
- Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease.
- Patient with active bleeding disorders.
- Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a White Blood Cell count of <3,000 cells/mm3 or documented or suspected liver disease (including laboratory evidence of Hepatitis B and C)
- Known renal insufficiency (e.g., estimated Glomerular Filtration rate <60 ml/kg/m² or Serum Creatinine level of > 2.0 mg/dL, or patient on dialysis).
- Patient has had a Cerebrovascular Accident (CVA) or Transient Ischemic Neurological Attack (TIA) within the past 6 months.
- Patient belonging to a vulnerable population (per Investigator's judgment, e.g., subordinate hospital staff or Sponsor staff).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Active Control, Open-label, Multinational, Randomized Clinical Trial Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems to Evaluate Safety and Performance in Patients With Long de Novo Lesions.
A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures.
Read more
All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure.
10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]
- Conditions
- Coronary Artery Disease
- Being tested
- BioMime™ Morph - Sirolimus Eluting Coronary Stent System, Xience family Everolimus Coronary Stent Systems
- 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.
BioMime™ Morph - Sirolimus Eluting Coronary Stent SystemDevice
Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
Xience family Everolimus Coronary Stent SystemsDevice
Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
| Study group | Role | What they receive |
|---|---|---|
| BioMime™ Morph - Sirolimus Eluting Coronary Stent System | Experimental | Not described Receives: Device: BioMime™ Morph - Sirolimus Eluting Coronary Stent System |
| Xience family Everolimus Coronary Stent Systems | Active comparator | Not described Receives: Device: Xience family Everolimus Coronary Stent Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization.
Measured: 6 months (±14 days)
Secondary outcomes (4)
Target Lesion Failure
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization.
Measured: 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month)
MACE
Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR).
Measured: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Stent Thrombosis Rate (As per Academic Research Consortium)
Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Measured: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Ischemia-driven Target Vessel Revascularization (ID-TVR)
Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start15 Sep 2019 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion22 Jun 2022 (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
- Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ertugrul Okuyan, Principal investigator, Bagcilar Egitim ve Arastirma HastanesiDr. Omer Kozan, Principal investigator, Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma HastanesiDr. Jan - Peter V Kuijk, Principal investigator, St. Antonius HospitalDr. Jakub Podolec, Principal investigator, Krakowski Szpital Specjalistyczny im. Jana Pawla IIDr. Andrzej Ochala, Principal investigator, Zaklad Kardiologii InwazyjnejDr. Oleg Polonetsky, Principal investigator, National Scientific and Practical Centre - CardiologyDr. Orazbek Sakhov, Principal investigator, City Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721614
- Sponsor's protocol ID
- MLS/Morph RCT-1
- Acronym
- Morph RCT-1
- Status last verified
- Aug 2019
- First submitted
- 23 Oct 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Active Control, Open-label, Multinational, Randomized Clinical Trial Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems to Evaluate Safety and Performance in Patients With Long de Novo Lesions.
- ClinicalTrials.gov ID
- NCT03721614
- Acronym / sponsor ID
- Morph RCT-1 / MLS/Morph RCT-1
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 26 Oct 2018 (actual)
- 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, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures.
All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure.
10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
| Arm | Type | Receives |
|---|---|---|
| BioMime™ Morph - Sirolimus Eluting Coronary Stent System | Experimental | Device: BioMime™ Morph - Sirolimus Eluting Coronary Stent System |
| Xience family Everolimus Coronary Stent Systems | Active comparator | Device: Xience family Everolimus Coronary Stent Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be at least ≥18 years of age.
- Significant de novo native coronary artery stenosis as part of Ischemic Heart Disease with lesion length of ≥26 mm and ≤56 mm (irrespective of number of lesions) with reference vessel diameter of (Proximal to Distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.50 - 3.00 mm.
- Patient with lesion(s), with a visually estimated stenosis of ≥50% and <100% with a TIMI flow of ≥1.
- Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. This includes clinical trials of medication and invasive procedures, questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
- Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal.
Key exclusion criteria (13 listed)
- Patients with known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, anti-platelet medication specified for use in the study, everolimus and sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure(Pregnancy should be confirmed based on positive urine pregnancy test as part of screening procedure)
- An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT.
- Patient has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Patient has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK-MB/Troponin T/Troponin I values have not returned to within normal limits at the time of 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 |
|---|---|---|
| BioMime™ Morph - Sirolimus Eluting Coronary Stent SystemStudy Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. | Device | BioMime™ Morph - Sirolimus Eluting Coronary Stent System |
| Xience family Everolimus Coronary Stent SystemsActive Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. | Device | Xience family Everolimus Coronary Stent Systems |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 6 months (±14 days)
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization.
4 secondary outcomes
Target Lesion Failure
Time frame: 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month)
MACE
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Stent Thrombosis Rate (As per Academic Research Consortium)
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Ischemia-driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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. Ertugrul Okuyan principal investigator
Bagcilar Egitim ve Arastirma Hastanesi
Dr. Omer Kozan principal investigator
Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi
Dr. Jan - Peter V Kuijk principal investigator
St. Antonius Hospital
Questions about this trial
What is this clinical trial studying?
A study testing BioMime™ Morph - Sirolimus Eluting Coronary Stent System and Xience family Everolimus Coronary Stent Systems in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
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 7 inclusion and 13 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Dr. Ashok Thakkar, Ph.D (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?
Target Lesion Failure (TLF) (time frame: 6 months (±14 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 14 Aug 2019.